Re: Long lasting testosterone- NEBIDO

[Guest guest]

That new NEBIDO sounds very encouraging to say the least, sure would give

us more time between shots. I hope it is produced soon for us all who will

be on T for the rest of our lives.

Blessings,

Roy

Vergel <nelsonvergel@...> wrote:

Indevus Reports Additional Positive Phase III Trial Data For NEBIDO®

Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) announced additional positive

results from its Phase III program for NEBIDO (testosterone undecanoate), a

long-acting injectable testosterone therapy under development for the treatment

of male hypogonadism. The trial data announced has been filed with the U.S. Food

and Drug Administration (FDA) as an addition to data contained in the Company's

existing New Drug Application (NDA) that was originally filed on August 28,

2007. Based on recent conversations with the FDA, the Company anticipates that

the FDA Prescription Drug User Fee Act (PDUFA) target action date for NEBIDO

will remain June 27, 2008.

The dosing regimen for NEBIDO submitted in the original NDA was 1000 mg given

every 12 weeks, and as announced previously, achieved all of the primary

endpoints according to the FDA criteria for approvability. The Company has been

exploring additional dosage regimens to determine if it is possible to achieve a

more rapid onset of steady state testosterone pharmacokinetics and still satisfy

each of the FDA pre-specified criteria for approvability. This recently

completed Phase III trial, announced today, studied a new treatment regimen in

which hypogonadal men were given an initial injection of 750 mg of NEBIDO,

followed 4-weeks later by an additional 750 mg loading injection and then 750 mg

injections every 10-weeks thereafter.

The data from this recently completed Phase III trial demonstrated a highly

effective treatment regimen. In the trial, NEBIDO demonstrated a rapid

achievement of steady state testosterone levels, minimal excursions outside of

the normal range, and an extremely high percentage of patients maintaining a

eugonadal (normal) testosterone range. NEBIDO met its primary endpoints, a

responder analysis based on average testosterone concentrations during the

steady state dosing interval and an outlier analysis based on the maximum

testosterone concentrations during the steady state dosing interval. As with the

original dosing regimen, treatment with NEBIDO was well tolerated with this new

dosing regimen.

" As we have previously stated, we have been evaluating dosing regimens that we

believe optimize the replacement of testosterone in men with hypogonadism. I am

extremely pleased that the dosing regimen evaluated in this study accomplishes

this objective, " stated Glenn L. , M.D., chairman and chief executive

officer of Indevus. " The results of our trial demonstrate a rapid achievement of

steady-state testosterone levels, the maintenance of levels within the eugonadal

range, and reductions in excursions above the normal range. Steady state

testosterone pharmacokinetics were achieved within just weeks under the new

regimen, whereas the 1000 mg regimen, while successfully achieving all primary

objectives, reached steady state pharmacokinetics after several months of

treatment. "

Dr. continued, " We intend to ask for approval of this new 750 mg regimen,

rather than the 1000 mg regimen, as we believe this new regimen distinguishes

itself by providing physicians with the optimal long-term dosing solution for

treating their male patients with hypogonadism. Importantly, we are extremely

pleased with the feedback we recently received from the FDA that the PDUFA

target action date was likely to remain unchanged. "

Study Design

The most recent Phase III pharmacokinetic trial was an open-label (unblinded)

study that evaluated treatment with an initial 750 mg of NEBIDO given via

intramuscular injection, followed 4-weeks later by an additional 750 mg loading

injection and then 750 mg every 10 weeks thereafter. Patients eligible for

pharmacokinetic assessment were males with a diagnosis of either primary or

secondary hypogonadism, a body weight >65 kg, and at least 18 years of age.

The primary endpoints included a responder analysis (based on guidelines

provided from the FDA for average testosterone concentrations over the steady

state dosing interval) and an outlier analysis (based on the maximum

testosterone concentrations during the steady state dosing interval).

Specifically, a responder was defined (per FDA approvability criteria) as a

patient who, during steady state, had an average concentration of serum total

testosterone (Cavg) within the normal range (300 to 1000 ng/dL). The primary

response endpoint was met if at least 75% of patients achieved a Cavg within

this normal range. FDA also provided guidelines related to maximum testosterone

(Cmax) levels, including thresholds that no patient should exceed a testosterone

concentration of 2500 ng/dL, no more than 5% of patients should exceed a

concentration of 1800 ng/dL, and no more than 15% of patients should exceed a

concentration of 1500 ng/dL.

In addition, secondary outcomes included measurements evaluating the general

health and well-being of the patients by physical examinations, clinical

laboratory measurements, questionnaires, and other assessments.

Study Findings

The trial enrolled a total of 130 male hypogonadal patients, with 117 (90%)

patients completing their data collection for the assessment of the primary

endpoints. Of these 117 patients, 94% had a Cavg within the normal range. None

of these patients exceeded a testosterone level of either 2500 ng/dL or 1800

ng/dL, and only nine of 117 (7.7%) patients had a peak level exceeding 1500

ng/dL. For those few patients exceeding the 1500 ng/dL threshold, the duration

of time above the threshold was brief. Patients also demonstrated improvements

from baseline in the key secondary clinical outcome variables.

NEBIDO was well-tolerated as indicated by the analysis of the safety

measurements collected and the persistence with study treatment. Further, the

spectrum of adverse events reported were comparable to other injectable

hypogonadism treatments reported in the literature. There were no significant

adverse changes in laboratory parameters with NEBIDO treatment.

About NEBIDO

NEBIDO® is a long-acting depot preparation of testosterone undecanoate under

development for the treatment of male hypogonadism. NEBIDO is expected to be the

first long-acting testosterone preparation available in the U.S. in the growing

market for testosterone replacement therapies. Indevus acquired U.S. rights to

NEBIDO from Bayer Schering Pharma AG, Germany in July 2005.

About Hypogonadism

Male hypogonadism is an increasingly recognized medical condition characterized

by a reduced or absent secretion of testosterone from the testes. Reduced

testosterone levels can lead to health problems and significantly impair quality

of life. Common effects of hypogonadism include decreased sexual desire,

erectile dysfunction, fatigue, muscle loss and weakness, depression, as well as

an increased risk of osteoporosis. Today, there are an estimated four to five

million men in the U.S. who suffer from hypogonadism. Of this group, less than

ten percent are currently receiving treatment with testosterone replacement

therapy.

Indevus Pharmaceuticals, Inc.

http://www.icadmed.com

Regards,

Vergel

powerusa dot org

[Guest guest]

There are a lot of guys in the UK that tried it and did not feel it lasted that

long most of them had to get shots in 4 week for something that is good for 4

months. Yet there are guys doing ok on this I don't feel this will go over very

well here is the US.

Roy <chickenbirdtree@...> wrote: That new NEBIDO sounds

very encouraging to say the least, sure would give

us more time between shots. I hope it is produced soon for us all who will

be on T for the rest of our lives.

Blessings,

Roy

Vergel <nelsonvergel@...> wrote:

Indevus Reports Additional Positive Phase III Trial Data For NEBIDO®

Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) announced additional positive

results from its Phase III program for NEBIDO (testosterone undecanoate), a

long-acting injectable testosterone therapy under development for the treatment

of male hypogonadism. The trial data announced has been filed with the U.S. Food

and Drug Administration (FDA) as an addition to data contained in the Company's

existing New Drug Application (NDA) that was originally filed on August 28,

2007. Based on recent conversations with the FDA, the Company anticipates that

the FDA Prescription Drug User Fee Act (PDUFA) target action date for NEBIDO

will remain June 27, 2008.

The dosing regimen for NEBIDO submitted in the original NDA was 1000 mg given

every 12 weeks, and as announced previously, achieved all of the primary

endpoints according to the FDA criteria for approvability. The Company has been

exploring additional dosage regimens to determine if it is possible to achieve a

more rapid onset of steady state testosterone pharmacokinetics and still satisfy

each of the FDA pre-specified criteria for approvability. This recently

completed Phase III trial, announced today, studied a new treatment regimen in

which hypogonadal men were given an initial injection of 750 mg of NEBIDO,

followed 4-weeks later by an additional 750 mg loading injection and then 750 mg

injections every 10-weeks thereafter.

The data from this recently completed Phase III trial demonstrated a highly

effective treatment regimen. In the trial, NEBIDO demonstrated a rapid

achievement of steady state testosterone levels, minimal excursions outside of

the normal range, and an extremely high percentage of patients maintaining a

eugonadal (normal) testosterone range. NEBIDO met its primary endpoints, a

responder analysis based on average testosterone concentrations during the

steady state dosing interval and an outlier analysis based on the maximum

testosterone concentrations during the steady state dosing interval. As with the

original dosing regimen, treatment with NEBIDO was well tolerated with this new

dosing regimen.

" As we have previously stated, we have been evaluating dosing regimens that we

believe optimize the replacement of testosterone in men with hypogonadism. I am

extremely pleased that the dosing regimen evaluated in this study accomplishes

this objective, " stated Glenn L. , M.D., chairman and chief executive

officer of Indevus. " The results of our trial demonstrate a rapid achievement of

steady-state testosterone levels, the maintenance of levels within the eugonadal

range, and reductions in excursions above the normal range. Steady state

testosterone pharmacokinetics were achieved within just weeks under the new

regimen, whereas the 1000 mg regimen, while successfully achieving all primary

objectives, reached steady state pharmacokinetics after several months of

treatment. "

Dr. continued, " We intend to ask for approval of this new 750 mg regimen,

rather than the 1000 mg regimen, as we believe this new regimen distinguishes

itself by providing physicians with the optimal long-term dosing solution for

treating their male patients with hypogonadism. Importantly, we are extremely

pleased with the feedback we recently received from the FDA that the PDUFA

target action date was likely to remain unchanged. "

Study Design

The most recent Phase III pharmacokinetic trial was an open-label (unblinded)

study that evaluated treatment with an initial 750 mg of NEBIDO given via

intramuscular injection, followed 4-weeks later by an additional 750 mg loading

injection and then 750 mg every 10 weeks thereafter. Patients eligible for

pharmacokinetic assessment were males with a diagnosis of either primary or

secondary hypogonadism, a body weight >65 kg, and at least 18 years of age.

The primary endpoints included a responder analysis (based on guidelines

provided from the FDA for average testosterone concentrations over the steady

state dosing interval) and an outlier analysis (based on the maximum

testosterone concentrations during the steady state dosing interval).

Specifically, a responder was defined (per FDA approvability criteria) as a

patient who, during steady state, had an average concentration of serum total

testosterone (Cavg) within the normal range (300 to 1000 ng/dL). The primary

response endpoint was met if at least 75% of patients achieved a Cavg within

this normal range. FDA also provided guidelines related to maximum testosterone

(Cmax) levels, including thresholds that no patient should exceed a testosterone

concentration of 2500 ng/dL, no more than 5% of patients should exceed a

concentration of 1800 ng/dL, and no more than 15% of patients should exceed a

concentration of 1500 ng/dL.

In addition, secondary outcomes included measurements evaluating the general

health and well-being of the patients by physical examinations, clinical

laboratory measurements, questionnaires, and other assessments.

Study Findings

The trial enrolled a total of 130 male hypogonadal patients, with 117 (90%)

patients completing their data collection for the assessment of the primary

endpoints. Of these 117 patients, 94% had a Cavg within the normal range. None

of these patients exceeded a testosterone level of either 2500 ng/dL or 1800

ng/dL, and only nine of 117 (7.7%) patients had a peak level exceeding 1500

ng/dL. For those few patients exceeding the 1500 ng/dL threshold, the duration

of time above the threshold was brief. Patients also demonstrated improvements

from baseline in the key secondary clinical outcome variables.

NEBIDO was well-tolerated as indicated by the analysis of the safety

measurements collected and the persistence with study treatment. Further, the

spectrum of adverse events reported were comparable to other injectable

hypogonadism treatments reported in the literature. There were no significant

adverse changes in laboratory parameters with NEBIDO treatment.

About NEBIDO

NEBIDO® is a long-acting depot preparation of testosterone undecanoate under

development for the treatment of male hypogonadism. NEBIDO is expected to be the

first long-acting testosterone preparation available in the U.S. in the growing

market for testosterone replacement therapies. Indevus acquired U.S. rights to

NEBIDO from Bayer Schering Pharma AG, Germany in July 2005.

About Hypogonadism

Male hypogonadism is an increasingly recognized medical condition characterized

by a reduced or absent secretion of testosterone from the testes. Reduced

testosterone levels can lead to health problems and significantly impair quality

of life. Common effects of hypogonadism include decreased sexual desire,

erectile dysfunction, fatigue, muscle loss and weakness, depression, as well as

an increased risk of osteoporosis. Today, there are an estimated four to five

million men in the U.S. who suffer from hypogonadism. Of this group, less than

ten percent are currently receiving treatment with testosterone replacement

therapy.

Indevus Pharmaceuticals, Inc.

http://www.icadmed.com

Regards,

Vergel

powerusa dot org

[Guest guest]

When I looked at the charts of T levels with

Neibido several years ago, it was pretty clear

they were spacing the shots was too far apart

and letting the T level drop far too low

for far too long. One on the papers

had a similar T level chart for one

of the common T ester in use current

on a two week shot schedule. It was clearly

too high at the start and too low

for at least the last 3 days as I recall.

My thought is that Nebido will be OK ONLY

IF one get big enough shot ever 3 weeks or

maybe 4 weeks.

That is to say the drug company instructions

will result in this form of T replacement

being largely unsuccessful.

That is my " ivory tower " view on the topic.

> Indevus Reports Additional Positive Phase III Trial Data For

NEBIDO®

>

> Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) announced additional

positive results from its Phase III program for NEBIDO (testosterone

undecanoate), a long-acting injectable testosterone therapy under

development for the treatment of male hypogonadism. The trial data

announced has been filed with the U.S. Food and Drug Administration

(FDA) as an addition to data contained in the Company's existing New

Drug Application (NDA) that was originally filed on August 28, 2007.

Based on recent conversations with the FDA, the Company anticipates

that the FDA Prescription Drug User Fee Act (PDUFA) target action date

for NEBIDO will remain June 27, 2008.

>

> The dosing regimen for NEBIDO submitted in the original NDA was 1000

mg given every 12 weeks, and as announced previously, achieved all of

the primary endpoints according to the FDA criteria for approvability.

The Company has been exploring additional dosage regimens to determine

if it is possible to achieve a more rapid onset of steady state

testosterone pharmacokinetics and still satisfy each of the FDA pre-

specified criteria for approvability. This recently completed Phase

III trial, announced today, studied a new treatment regimen in which

hypogonadal men were given an initial injection of 750 mg of NEBIDO,

followed 4-weeks later by an additional 750 mg loading injection and

then 750 mg injections every 10-weeks thereafter.

>

> The data from this recently completed Phase III trial demonstrated a

highly effective treatment regimen. In the trial, NEBIDO demonstrated

a rapid achievement of steady state testosterone levels, minimal

excursions outside of the normal range, and an extremely high

percentage of patients maintaining a eugonadal (normal) testosterone

range. NEBIDO met its primary endpoints, a responder analysis based on

average testosterone concentrations during the steady state dosing

interval and an outlier analysis based on the maximum testosterone

concentrations during the steady state dosing interval. As with the

original dosing regimen, treatment with NEBIDO was well tolerated with

this new dosing regimen.

>

> " As we have previously stated, we have been evaluating dosing

regimens that we believe optimize the replacement of testosterone in

men with hypogonadism. I am extremely pleased that the dosing regimen

evaluated in this study accomplishes this objective, " stated Glenn L.

, M.D., chairman and chief executive officer of Indevus. " The

results of our trial demonstrate a rapid achievement of steady-state

testosterone levels, the maintenance of levels within the eugonadal

range, and reductions in excursions above the normal range. Steady

state testosterone pharmacokinetics were achieved within just weeks

under the new regimen, whereas the 1000 mg regimen, while successfully

achieving all primary objectives, reached steady state

pharmacokinetics after several months of treatment. "

>

> Dr. continued, " We intend to ask for approval of this new 750

mg regimen, rather than the 1000 mg regimen, as we believe this new

regimen distinguishes itself by providing physicians with the optimal

long-term dosing solution for treating their male patients with

hypogonadism. Importantly, we are extremely pleased with the feedback

we recently received from the FDA that the PDUFA target action date

was likely to remain unchanged. "

>

> Study Design

>

> The most recent Phase III pharmacokinetic trial was an open-label

(unblinded) study that evaluated treatment with an initial 750 mg of

NEBIDO given via intramuscular injection, followed 4-weeks later by an

additional 750 mg loading injection and then 750 mg every 10 weeks

thereafter. Patients eligible for pharmacokinetic assessment were

males with a diagnosis of either primary or secondary hypogonadism, a

body weight >65 kg, and at least 18 years of age.

>

> The primary endpoints included a responder analysis (based on

guidelines provided from the FDA for average testosterone

concentrations over the steady state dosing interval) and an outlier

analysis (based on the maximum testosterone concentrations during the

steady state dosing interval). Specifically, a responder was defined

(per FDA approvability criteria) as a patient who, during steady

state, had an average concentration of serum total testosterone (Cavg)

within the normal range (300 to 1000 ng/dL). The primary response

endpoint was met if at least 75% of patients achieved a Cavg within

this normal range. FDA also provided guidelines related to maximum

testosterone (Cmax) levels, including thresholds that no patient

should exceed a testosterone concentration of 2500 ng/dL, no more than

5% of patients should exceed a concentration of 1800 ng/dL, and no

more than 15% of patients should exceed a concentration of 1500 ng/dL.

>

> In addition, secondary outcomes included measurements evaluating the

general health and well-being of the patients by physical

examinations, clinical laboratory measurements, questionnaires, and

other assessments.

>

> Study Findings

>

> The trial enrolled a total of 130 male hypogonadal patients, with

117 (90%) patients completing their data collection for the assessment

of the primary endpoints. Of these 117 patients, 94% had a Cavg within

the normal range. None of these patients exceeded a testosterone level

of either 2500 ng/dL or 1800 ng/dL, and only nine of 117 (7.7%)

patients had a peak level exceeding 1500 ng/dL. For those few patients

exceeding the 1500 ng/dL threshold, the duration of time above the

threshold was brief. Patients also demonstrated improvements from

baseline in the key secondary clinical outcome variables.

>

> NEBIDO was well-tolerated as indicated by the analysis of the safety

measurements collected and the persistence with study treatment.

Further, the spectrum of adverse events reported were comparable to

other injectable hypogonadism treatments reported in the literature.

There were no significant adverse changes in laboratory parameters

with NEBIDO treatment.

>

> About NEBIDO

>

> NEBIDO® is a long-acting depot preparation of testosterone

undecanoate under development for the treatment of male hypogonadism.

NEBIDO is expected to be the first long-acting testosterone

preparation available in the U.S. in the growing market for

testosterone replacement therapies. Indevus acquired U.S. rights to

NEBIDO from Bayer Schering Pharma AG, Germany in July 2005.

>

> About Hypogonadism

>

> Male hypogonadism is an increasingly recognized medical condition

characterized by a reduced or absent secretion of testosterone from

the testes. Reduced testosterone levels can lead to health problems

and significantly impair quality of life. Common effects of

hypogonadism include decreased sexual desire, erectile dysfunction,

fatigue, muscle loss and weakness, depression, as well as an increased

risk of osteoporosis. Today, there are an estimated four to five

million men in the U.S. who suffer from hypogonadism. Of this group,

less than ten percent are currently receiving treatment with

testosterone replacement therapy.

>

> Indevus Pharmaceuticals, Inc.

> http://www.icadmed.com

>

> Regards,

>

> Vergel

> powerusa dot org

>

>

[Guest guest]

http://www.andrologyjournal.org/cgi/reprint/19/6/761

This link has some charts on levels of T from a TU bolus

shot over the course of 3 months.

It should be the pilot II study by

Sigrid Von Eckardstein and Eberhard Nieschlag.

I'll add I wasn't take impressed with

Nieschlag book Andrology from the late 90's.

It seemed to be a product of the " ivory tower. "

> > Indevus Reports Additional Positive Phase III Trial Data For

> NEBIDO®

> >

> > Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) announced additional

> positive results from its Phase III program for NEBIDO (testosterone

> undecanoate), a long-acting injectable testosterone therapy under

> development for the treatment of male hypogonadism. The trial data

> announced has been filed with the U.S. Food and Drug Administration

> (FDA) as an addition to data contained in the Company's existing New

> Drug Application (NDA) that was originally filed on August 28, 2007.

> Based on recent conversations with the FDA, the Company anticipates

> that the FDA Prescription Drug User Fee Act (PDUFA) target action

date

> for NEBIDO will remain June 27, 2008.

> >

> > The dosing regimen for NEBIDO submitted in the original NDA was

1000

> mg given every 12 weeks, and as announced previously, achieved all

of

> the primary endpoints according to the FDA criteria for

approvability.

> The Company has been exploring additional dosage regimens to

determine

> if it is possible to achieve a more rapid onset of steady state

> testosterone pharmacokinetics and still satisfy each of the FDA pre-

> specified criteria for approvability. This recently completed Phase

> III trial, announced today, studied a new treatment regimen in which

> hypogonadal men were given an initial injection of 750 mg of NEBIDO,

> followed 4-weeks later by an additional 750 mg loading injection and

> then 750 mg injections every 10-weeks thereafter.

> >

> > The data from this recently completed Phase III trial demonstrated

a

> highly effective treatment regimen. In the trial, NEBIDO

demonstrated

> a rapid achievement of steady state testosterone levels, minimal

> excursions outside of the normal range, and an extremely high

> percentage of patients maintaining a eugonadal (normal) testosterone

> range. NEBIDO met its primary endpoints, a responder analysis based

on

> average testosterone concentrations during the steady state dosing

> interval and an outlier analysis based on the maximum testosterone

> concentrations during the steady state dosing interval. As with the

> original dosing regimen, treatment with NEBIDO was well tolerated

with

> this new dosing regimen.

> >

> > " As we have previously stated, we have been evaluating dosing

> regimens that we believe optimize the replacement of testosterone in

> men with hypogonadism. I am extremely pleased that the dosing

regimen

> evaluated in this study accomplishes this objective, " stated Glenn

L.

> , M.D., chairman and chief executive officer of Indevus. " The

> results of our trial demonstrate a rapid achievement of steady-state

> testosterone levels, the maintenance of levels within the eugonadal

> range, and reductions in excursions above the normal range. Steady

> state testosterone pharmacokinetics were achieved within just weeks

> under the new regimen, whereas the 1000 mg regimen, while

successfully

> achieving all primary objectives, reached steady state

> pharmacokinetics after several months of treatment. "

> >

> > Dr. continued, " We intend to ask for approval of this new

750

> mg regimen, rather than the 1000 mg regimen, as we believe this new

> regimen distinguishes itself by providing physicians with the

optimal

> long-term dosing solution for treating their male patients with

> hypogonadism. Importantly, we are extremely pleased with the

feedback

> we recently received from the FDA that the PDUFA target action date

> was likely to remain unchanged. "

> >

> > Study Design

> >

> > The most recent Phase III pharmacokinetic trial was an open-label

> (unblinded) study that evaluated treatment with an initial 750 mg of

> NEBIDO given via intramuscular injection, followed 4-weeks later by

an

> additional 750 mg loading injection and then 750 mg every 10 weeks

> thereafter. Patients eligible for pharmacokinetic assessment were

> males with a diagnosis of either primary or secondary hypogonadism,

a

> body weight >65 kg, and at least 18 years of age.

> >

> > The primary endpoints included a responder analysis (based on

> guidelines provided from the FDA for average testosterone

> concentrations over the steady state dosing interval) and an outlier

> analysis (based on the maximum testosterone concentrations during

the

> steady state dosing interval). Specifically, a responder was defined

> (per FDA approvability criteria) as a patient who, during steady

> state, had an average concentration of serum total testosterone

(Cavg)

> within the normal range (300 to 1000 ng/dL). The primary response

> endpoint was met if at least 75% of patients achieved a Cavg within

> this normal range. FDA also provided guidelines related to maximum

> testosterone (Cmax) levels, including thresholds that no patient

> should exceed a testosterone concentration of 2500 ng/dL, no more

than

> 5% of patients should exceed a concentration of 1800 ng/dL, and no

> more than 15% of patients should exceed a concentration of 1500 ng/

dL.

> >

> > In addition, secondary outcomes included measurements evaluating

the

> general health and well-being of the patients by physical

> examinations, clinical laboratory measurements, questionnaires, and

> other assessments.

> >

> > Study Findings

> >

> > The trial enrolled a total of 130 male hypogonadal patients, with

> 117 (90%) patients completing their data collection for the

assessment

> of the primary endpoints. Of these 117 patients, 94% had a Cavg

within

> the normal range. None of these patients exceeded a testosterone

level

> of either 2500 ng/dL or 1800 ng/dL, and only nine of 117 (7.7%)

> patients had a peak level exceeding 1500 ng/dL. For those few

patients

> exceeding the 1500 ng/dL threshold, the duration of time above the

> threshold was brief. Patients also demonstrated improvements from

> baseline in the key secondary clinical outcome variables.

> >

> > NEBIDO was well-tolerated as indicated by the analysis of the

safety

> measurements collected and the persistence with study treatment.

> Further, the spectrum of adverse events reported were comparable to

> other injectable hypogonadism treatments reported in the literature.

> There were no significant adverse changes in laboratory parameters

> with NEBIDO treatment.

> >

> > About NEBIDO

> >

> > NEBIDO® is a long-acting depot preparation of testosterone

> undecanoate under development for the treatment of male

hypogonadism.

> NEBIDO is expected to be the first long-acting testosterone

> preparation available in the U.S. in the growing market for

> testosterone replacement therapies. Indevus acquired U.S. rights to

> NEBIDO from Bayer Schering Pharma AG, Germany in July 2005.

> >

> > About Hypogonadism

> >

> > Male hypogonadism is an increasingly recognized medical condition

> characterized by a reduced or absent secretion of testosterone from

> the testes. Reduced testosterone levels can lead to health problems

> and significantly impair quality of life. Common effects of

> hypogonadism include decreased sexual desire, erectile dysfunction,

> fatigue, muscle loss and weakness, depression, as well as an

increased

> risk of osteoporosis. Today, there are an estimated four to five

> million men in the U.S. who suffer from hypogonadism. Of this group,

> less than ten percent are currently receiving treatment with

> testosterone replacement therapy.

> >

> > Indevus Pharmaceuticals, Inc.

> > http://www.icadmed.com

> >

> > Regards,

> >

> > Vergel

> > powerusa dot org

> >

> >

[Guest guest]

I have been on Nebido (1000 ml) since June 07. Followed the guidelines - second

shot 6

weeks after the first and then the third after 12 weeks. Blood tests showed the

12 week

interval is way too optimistic. Now I am taking it every 6 weeks (the last 2

shots) and T

levels are around 500. The test after 10 weeks showed T at 350. But then again -

as was

confirmed by my urologist - we are all different. What works for one may be

inadequate or

too much for the other. My advice is to start out with following the prescribed

intervals, do

montly hormone testing and adjust time between shots accordingly.

Tomas

> > Indevus Reports Additional Positive Phase III Trial Data For

> NEBIDO®

> >

> > Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) announced additional

> positive results from its Phase III program for NEBIDO (testosterone

> undecanoate), a long-acting injectable testosterone therapy under

> development for the treatment of male hypogonadism. The trial data

> announced has been filed with the U.S. Food and Drug Administration

> (FDA) as an addition to data contained in the Company's existing New

> Drug Application (NDA) that was originally filed on August 28, 2007.

> Based on recent conversations with the FDA, the Company anticipates

> that the FDA Prescription Drug User Fee Act (PDUFA) target action date

> for NEBIDO will remain June 27, 2008.

> >

> > The dosing regimen for NEBIDO submitted in the original NDA was 1000

> mg given every 12 weeks, and as announced previously, achieved all of

> the primary endpoints according to the FDA criteria for approvability.

> The Company has been exploring additional dosage regimens to determine

> if it is possible to achieve a more rapid onset of steady state

> testosterone pharmacokinetics and still satisfy each of the FDA pre-

> specified criteria for approvability. This recently completed Phase

> III trial, announced today, studied a new treatment regimen in which

> hypogonadal men were given an initial injection of 750 mg of NEBIDO,

> followed 4-weeks later by an additional 750 mg loading injection and

> then 750 mg injections every 10-weeks thereafter.

> >

> > The data from this recently completed Phase III trial demonstrated a

> highly effective treatment regimen. In the trial, NEBIDO demonstrated

> a rapid achievement of steady state testosterone levels, minimal

> excursions outside of the normal range, and an extremely high

> percentage of patients maintaining a eugonadal (normal) testosterone

> range. NEBIDO met its primary endpoints, a responder analysis based on

> average testosterone concentrations during the steady state dosing

> interval and an outlier analysis based on the maximum testosterone

> concentrations during the steady state dosing interval. As with the

> original dosing regimen, treatment with NEBIDO was well tolerated with

> this new dosing regimen.

> >

> > " As we have previously stated, we have been evaluating dosing

> regimens that we believe optimize the replacement of testosterone in

> men with hypogonadism. I am extremely pleased that the dosing regimen

> evaluated in this study accomplishes this objective, " stated Glenn L.

> , M.D., chairman and chief executive officer of Indevus. " The

> results of our trial demonstrate a rapid achievement of steady-state

> testosterone levels, the maintenance of levels within the eugonadal

> range, and reductions in excursions above the normal range. Steady

> state testosterone pharmacokinetics were achieved within just weeks

> under the new regimen, whereas the 1000 mg regimen, while successfully

> achieving all primary objectives, reached steady state

> pharmacokinetics after several months of treatment. "

> >

> > Dr. continued, " We intend to ask for approval of this new 750

> mg regimen, rather than the 1000 mg regimen, as we believe this new

> regimen distinguishes itself by providing physicians with the optimal

> long-term dosing solution for treating their male patients with

> hypogonadism. Importantly, we are extremely pleased with the feedback

> we recently received from the FDA that the PDUFA target action date

> was likely to remain unchanged. "

> >

> > Study Design

> >

> > The most recent Phase III pharmacokinetic trial was an open-label

> (unblinded) study that evaluated treatment with an initial 750 mg of

> NEBIDO given via intramuscular injection, followed 4-weeks later by an

> additional 750 mg loading injection and then 750 mg every 10 weeks

> thereafter. Patients eligible for pharmacokinetic assessment were

> males with a diagnosis of either primary or secondary hypogonadism, a

> body weight >65 kg, and at least 18 years of age.

> >

> > The primary endpoints included a responder analysis (based on

> guidelines provided from the FDA for average testosterone

> concentrations over the steady state dosing interval) and an outlier

> analysis (based on the maximum testosterone concentrations during the

> steady state dosing interval). Specifically, a responder was defined

> (per FDA approvability criteria) as a patient who, during steady

> state, had an average concentration of serum total testosterone (Cavg)

> within the normal range (300 to 1000 ng/dL). The primary response

> endpoint was met if at least 75% of patients achieved a Cavg within

> this normal range. FDA also provided guidelines related to maximum

> testosterone (Cmax) levels, including thresholds that no patient

> should exceed a testosterone concentration of 2500 ng/dL, no more than

> 5% of patients should exceed a concentration of 1800 ng/dL, and no

> more than 15% of patients should exceed a concentration of 1500 ng/dL.

> >

> > In addition, secondary outcomes included measurements evaluating the

> general health and well-being of the patients by physical

> examinations, clinical laboratory measurements, questionnaires, and

> other assessments.

> >

> > Study Findings

> >

> > The trial enrolled a total of 130 male hypogonadal patients, with

> 117 (90%) patients completing their data collection for the assessment

> of the primary endpoints. Of these 117 patients, 94% had a Cavg within

> the normal range. None of these patients exceeded a testosterone level

> of either 2500 ng/dL or 1800 ng/dL, and only nine of 117 (7.7%)

> patients had a peak level exceeding 1500 ng/dL. For those few patients

> exceeding the 1500 ng/dL threshold, the duration of time above the

> threshold was brief. Patients also demonstrated improvements from

> baseline in the key secondary clinical outcome variables.

> >

> > NEBIDO was well-tolerated as indicated by the analysis of the safety

> measurements collected and the persistence with study treatment.

> Further, the spectrum of adverse events reported were comparable to

> other injectable hypogonadism treatments reported in the literature.

> There were no significant adverse changes in laboratory parameters

> with NEBIDO treatment.

> >

> > About NEBIDO

> >

> > NEBIDO® is a long-acting depot preparation of testosterone

> undecanoate under development for the treatment of male hypogonadism.

> NEBIDO is expected to be the first long-acting testosterone

> preparation available in the U.S. in the growing market for

> testosterone replacement therapies. Indevus acquired U.S. rights to

> NEBIDO from Bayer Schering Pharma AG, Germany in July 2005.

> >

> > About Hypogonadism

> >

> > Male hypogonadism is an increasingly recognized medical condition

> characterized by a reduced or absent secretion of testosterone from

> the testes. Reduced testosterone levels can lead to health problems

> and significantly impair quality of life. Common effects of

> hypogonadism include decreased sexual desire, erectile dysfunction,

> fatigue, muscle loss and weakness, depression, as well as an increased

> risk of osteoporosis. Today, there are an estimated four to five

> million men in the U.S. who suffer from hypogonadism. Of this group,

> less than ten percent are currently receiving treatment with

> testosterone replacement therapy.

> >

> > Indevus Pharmaceuticals, Inc.

> > http://www.icadmed.com

> >

> > Regards,

> >

> > Vergel

> > powerusa dot org

> >

> >

[Guest guest]

What is your/their target for your total Testosterone

level? I'd hope it is higher than 500 and more

say 800.

I'll check the archive to see if you say how

you feel on it.

It seems in Asians, Nebido all by itself is

a fairly successful means of suppressing sperm

production. In persons of native European descent

this is less true. Hence the endos that are

experimenting with it as a birth control drug

have been adding a progestrone like drug/hormone.

Over the long term, I'd bet Nebido gets to be

more effective even when taken alone as hormone

replacement in all genetic groups.

And these are the same endos that seem to think a value

of 301 ng/dL is OK.

> > > Indevus Reports Additional Positive Phase III Trial Data For

> > NEBIDO®

> > >

> > > Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) announced

additional

> > positive results from its Phase III program for NEBIDO

(testosterone

> > undecanoate), a long-acting injectable testosterone therapy under

> > development for the treatment of male hypogonadism. The trial data

> > announced has been filed with the U.S. Food and Drug

Administration

> > (FDA) as an addition to data contained in the Company's existing

New

> > Drug Application (NDA) that was originally filed on August 28,

2007.

> > Based on recent conversations with the FDA, the Company

anticipates

> > that the FDA Prescription Drug User Fee Act (PDUFA) target action

date

> > for NEBIDO will remain June 27, 2008.

> > >

> > > The dosing regimen for NEBIDO submitted in the original NDA was

1000

> > mg given every 12 weeks, and as announced previously, achieved all

of

> > the primary endpoints according to the FDA criteria for

approvability.

> > The Company has been exploring additional dosage regimens to

determine

> > if it is possible to achieve a more rapid onset of steady state

> > testosterone pharmacokinetics and still satisfy each of the FDA

pre-

> > specified criteria for approvability. This recently completed

Phase

> > III trial, announced today, studied a new treatment regimen in

which

> > hypogonadal men were given an initial injection of 750 mg of

NEBIDO,

> > followed 4-weeks later by an additional 750 mg loading injection

and

> > then 750 mg injections every 10-weeks thereafter.

> > >

> > > The data from this recently completed Phase III trial

demonstrated a

> > highly effective treatment regimen. In the trial, NEBIDO

demonstrated

> > a rapid achievement of steady state testosterone levels, minimal

> > excursions outside of the normal range, and an extremely high

> > percentage of patients maintaining a eugonadal (normal)

testosterone

> > range. NEBIDO met its primary endpoints, a responder analysis

based on

> > average testosterone concentrations during the steady state dosing

> > interval and an outlier analysis based on the maximum testosterone

> > concentrations during the steady state dosing interval. As with

the

> > original dosing regimen, treatment with NEBIDO was well tolerated

with

> > this new dosing regimen.

> > >

> > > " As we have previously stated, we have been evaluating dosing

> > regimens that we believe optimize the replacement of testosterone

in

> > men with hypogonadism. I am extremely pleased that the dosing

regimen

> > evaluated in this study accomplishes this objective, " stated Glenn

L.

> > , M.D., chairman and chief executive officer of Indevus.

" The

> > results of our trial demonstrate a rapid achievement of steady-

state

> > testosterone levels, the maintenance of levels within the

eugonadal

> > range, and reductions in excursions above the normal range. Steady

> > state testosterone pharmacokinetics were achieved within just

weeks

> > under the new regimen, whereas the 1000 mg regimen, while

successfully

> > achieving all primary objectives, reached steady state

> > pharmacokinetics after several months of treatment. "

> > >

> > > Dr. continued, " We intend to ask for approval of this new

750

> > mg regimen, rather than the 1000 mg regimen, as we believe this

new

> > regimen distinguishes itself by providing physicians with the

optimal

> > long-term dosing solution for treating their male patients with

> > hypogonadism. Importantly, we are extremely pleased with the

feedback

> > we recently received from the FDA that the PDUFA target action

date

> > was likely to remain unchanged. "

> > >

> > > Study Design

> > >

> > > The most recent Phase III pharmacokinetic trial was an open-

label

> > (unblinded) study that evaluated treatment with an initial 750 mg

of

> > NEBIDO given via intramuscular injection, followed 4-weeks later

by an

> > additional 750 mg loading injection and then 750 mg every 10 weeks

> > thereafter. Patients eligible for pharmacokinetic assessment were

> > males with a diagnosis of either primary or secondary

hypogonadism, a

> > body weight >65 kg, and at least 18 years of age.

> > >

> > > The primary endpoints included a responder analysis (based on

> > guidelines provided from the FDA for average testosterone

> > concentrations over the steady state dosing interval) and an

outlier

> > analysis (based on the maximum testosterone concentrations during

the

> > steady state dosing interval). Specifically, a responder was

defined

> > (per FDA approvability criteria) as a patient who, during steady

> > state, had an average concentration of serum total testosterone

(Cavg)

> > within the normal range (300 to 1000 ng/dL). The primary response

> > endpoint was met if at least 75% of patients achieved a Cavg

within

> > this normal range. FDA also provided guidelines related to maximum

> > testosterone (Cmax) levels, including thresholds that no patient

> > should exceed a testosterone concentration of 2500 ng/dL, no more

than

> > 5% of patients should exceed a concentration of 1800 ng/dL, and no

> > more than 15% of patients should exceed a concentration of 1500

ng/dL.

> > >

> > > In addition, secondary outcomes included measurements evaluating

the

> > general health and well-being of the patients by physical

> > examinations, clinical laboratory measurements, questionnaires,

and

> > other assessments.

> > >

> > > Study Findings

> > >

> > > The trial enrolled a total of 130 male hypogonadal patients,

with

> > 117 (90%) patients completing their data collection for the

assessment

> > of the primary endpoints. Of these 117 patients, 94% had a Cavg

within

> > the normal range. None of these patients exceeded a testosterone

level

> > of either 2500 ng/dL or 1800 ng/dL, and only nine of 117 (7.7%)

> > patients had a peak level exceeding 1500 ng/dL. For those few

patients

> > exceeding the 1500 ng/dL threshold, the duration of time above the

> > threshold was brief. Patients also demonstrated improvements from

> > baseline in the key secondary clinical outcome variables.

> > >

> > > NEBIDO was well-tolerated as indicated by the analysis of the

safety

> > measurements collected and the persistence with study treatment.

> > Further, the spectrum of adverse events reported were comparable

to

> > other injectable hypogonadism treatments reported in the

literature.

> > There were no significant adverse changes in laboratory parameters

> > with NEBIDO treatment.

> > >

> > > About NEBIDO

> > >

> > > NEBIDO® is a long-acting depot preparation of testosterone

> > undecanoate under development for the treatment of male

hypogonadism.

> > NEBIDO is expected to be the first long-acting testosterone

> > preparation available in the U.S. in the growing market for

> > testosterone replacement therapies. Indevus acquired U.S. rights

to

> > NEBIDO from Bayer Schering Pharma AG, Germany in July 2005.

> > >

> > > About Hypogonadism

> > >

> > > Male hypogonadism is an increasingly recognized medical

condition

> > characterized by a reduced or absent secretion of testosterone

from

> > the testes. Reduced testosterone levels can lead to health

problems

> > and significantly impair quality of life. Common effects of

> > hypogonadism include decreased sexual desire, erectile

dysfunction,

> > fatigue, muscle loss and weakness, depression, as well as an

increased

> > risk of osteoporosis. Today, there are an estimated four to five

> > million men in the U.S. who suffer from hypogonadism. Of this

group,

> > less than ten percent are currently receiving treatment with

> > testosterone replacement therapy.

> > >

> > > Indevus Pharmaceuticals, Inc.

> > > http://www.icadmed.com

> > >

> > > Regards,

> > >

> > > Vergel

> > > powerusa dot org

> > >

> > >

[Guest guest]

I'm in the 750 mg test group. It works well. I go every 10 weeks for a new

shot. My T does go up right after the shot, but it's pretty consistent

until time for the next shot.

On Jan 29, 2008 2:13 PM, philip georgian <pmgamer18@...> wrote:

> There are a lot of guys in the UK that tried it and did not feel it

> lasted that long most of them had to get shots in 4 week for something that

> is good for 4 months. Yet there are guys doing ok on this I don't feel this

> will go over very well here is the US.

>

> Roy <chickenbirdtree@... <chickenbirdtree%40>>

> wrote: That new NEBIDO sounds very encouraging to say the least, sure would

> give

>

> us more time between shots. I hope it is produced soon for us all who will

> be on T for the rest of our lives.

> Blessings,

> Roy

>

> Vergel <nelsonvergel@... <nelsonvergel%40>> wrote:

> Indevus Reports Additional Positive Phase III Trial Data For NEBIDO®

>

> Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) announced additional positive

> results from its Phase III program for NEBIDO (testosterone undecanoate), a

> long-acting injectable testosterone therapy under development for the

> treatment of male hypogonadism. The trial data announced has been filed with

> the U.S. Food and Drug Administration (FDA) as an addition to data

> contained in the Company's existing New Drug Application (NDA) that was

> originally filed on August 28, 2007. Based on recent conversations with the

> FDA, the Company anticipates that the FDA Prescription Drug User Fee Act

> (PDUFA) target action date for NEBIDO will remain June 27, 2008.

>

> The dosing regimen for NEBIDO submitted in the original NDA was 1000 mg

> given every 12 weeks, and as announced previously, achieved all of the

> primary endpoints according to the FDA criteria for approvability. The

> Company has been exploring additional dosage regimens to determine if it is

> possible to achieve a more rapid onset of steady state testosterone

> pharmacokinetics and still satisfy each of the FDA pre-specified criteria

> for approvability. This recently completed Phase III trial, announced today,

> studied a new treatment regimen in which hypogonadal men were given an

> initial injection of 750 mg of NEBIDO, followed 4-weeks later by an

> additional 750 mg loading injection and then 750 mg injections every

> 10-weeks thereafter.

>

> The data from this recently completed Phase III trial demonstrated a

> highly effective treatment regimen. In the trial, NEBIDO demonstrated a

> rapid achievement of steady state testosterone levels, minimal excursions

> outside of the normal range, and an extremely high percentage of patients

> maintaining a eugonadal (normal) testosterone range. NEBIDO met its primary

> endpoints, a responder analysis based on average testosterone concentrations

> during the steady state dosing interval and an outlier analysis based on the

> maximum testosterone concentrations during the steady state dosing interval.

> As with the original dosing regimen, treatment with NEBIDO was well

> tolerated with this new dosing regimen.

>

> " As we have previously stated, we have been evaluating dosing regimens

> that we believe optimize the replacement of testosterone in men with

> hypogonadism. I am extremely pleased that the dosing regimen evaluated in

> this study accomplishes this objective, " stated Glenn L. , M.D.,

> chairman and chief executive officer of Indevus. " The results of our trial

> demonstrate a rapid achievement of steady-state testosterone levels, the

> maintenance of levels within the eugonadal range, and reductions in

> excursions above the normal range. Steady state testosterone

> pharmacokinetics were achieved within just weeks under the new regimen,

> whereas the 1000 mg regimen, while successfully achieving all primary

> objectives, reached steady state pharmacokinetics after several months of

> treatment. "

>

> Dr. continued, " We intend to ask for approval of this new 750 mg

> regimen, rather than the 1000 mg regimen, as we believe this new regimen

> distinguishes itself by providing physicians with the optimal long-term

> dosing solution for treating their male patients with hypogonadism.

> Importantly, we are extremely pleased with the feedback we recently received

> from the FDA that the PDUFA target action date was likely to remain

> unchanged. "

>

> Study Design

>

> The most recent Phase III pharmacokinetic trial was an open-label

> (unblinded) study that evaluated treatment with an initial 750 mg of NEBIDO

> given via intramuscular injection, followed 4-weeks later by an additional

> 750 mg loading injection and then 750 mg every 10 weeks thereafter. Patients

> eligible for pharmacokinetic assessment were males with a diagnosis of

> either primary or secondary hypogonadism, a body weight >65 kg, and at least

> 18 years of age.

>

> The primary endpoints included a responder analysis (based on guidelines

> provided from the FDA for average testosterone concentrations over the

> steady state dosing interval) and an outlier analysis (based on the maximum

> testosterone concentrations during the steady state dosing interval).

> Specifically, a responder was defined (per FDA approvability criteria) as a

> patient who, during steady state, had an average concentration of serum

> total testosterone (Cavg) within the normal range (300 to 1000 ng/dL). The

> primary response endpoint was met if at least 75% of patients achieved a

> Cavg within this normal range. FDA also provided guidelines related to

> maximum testosterone (Cmax) levels, including thresholds that no patient

> should exceed a testosterone concentration of 2500 ng/dL, no more than 5% of

> patients should exceed a concentration of 1800 ng/dL, and no more than 15%

> of patients should exceed a concentration of 1500 ng/dL.

>

> In addition, secondary outcomes included measurements evaluating the

> general health and well-being of the patients by physical examinations,

> clinical laboratory measurements, questionnaires, and other assessments.

>

> Study Findings

>

> The trial enrolled a total of 130 male hypogonadal patients, with 117

> (90%) patients completing their data collection for the assessment of the

> primary endpoints. Of these 117 patients, 94% had a Cavg within the normal

> range. None of these patients exceeded a testosterone level of either 2500

> ng/dL or 1800 ng/dL, and only nine of 117 (7.7%) patients had a peak level

> exceeding 1500 ng/dL. For those few patients exceeding the 1500 ng/dL

> threshold, the duration of time above the threshold was brief. Patients also

> demonstrated improvements from baseline in the key secondary clinical

> outcome variables.

>

> NEBIDO was well-tolerated as indicated by the analysis of the safety

> measurements collected and the persistence with study treatment. Further,

> the spectrum of adverse events reported were comparable to other injectable

> hypogonadism treatments reported in the literature. There were no

> significant adverse changes in laboratory parameters with NEBIDO treatment.

>

> About NEBIDO

>

> NEBIDO® is a long-acting depot preparation of testosterone undecanoate

> under development for the treatment of male hypogonadism. NEBIDO is expected

> to be the first long-acting testosterone preparation available in the U.S.

> in the growing market for testosterone replacement therapies. Indevus

> acquired U.S. rights to NEBIDO from Bayer Schering Pharma AG, Germany in

> July 2005.

>

> About Hypogonadism

>

> Male hypogonadism is an increasingly recognized medical condition

> characterized by a reduced or absent secretion of testosterone from the

> testes. Reduced testosterone levels can lead to health problems and

> significantly impair quality of life. Common effects of hypogonadism include

> decreased sexual desire, erectile dysfunction, fatigue, muscle loss and

> weakness, depression, as well as an increased risk of osteoporosis. Today,

> there are an estimated four to five million men in the U.S. who suffer

> from hypogonadism. Of this group, less than ten percent are currently

> receiving treatment with testosterone replacement therapy.

>

> Indevus Pharmaceuticals, Inc.

> http://www.icadmed.com

>

> Regards,

>

> Vergel

> powerusa dot org

>

>