Milnacipran - another FMS drug nearing FDA approval!

[Guest guest]

Good News…

Milnacipran is

in the final stages of clinical trials – it will soon be the next FDA

approved medication for FMS! It has been studied for several years

specifically for FMS, although it has been approved for other illnesses for

some time.

Below is a research

update back from February, 2004, when Dr. Katz was recruiting participants for

a milnacipran study taking place at his location. At that time, we were

thinking this would end up being the first medication to be FDA approved, but

Lyrica came in first.

There was a

lot of research presented at the ACR meeting in November about Milnacipran

studies, and it has a lot of people excited that there will soon be more

options for fibromyalgia.

So – for

those of you who do not tolerate Lyrica, maybe Milnacipran will work for you!

Happy New

Year!

Shari Ferbert

www.AFFTER.org

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

RESEARCH UPDATE –

Study participants needed! February, 2004

In order for fibromyalgia

and chronic fatigue syndrome to see progress in research, there needs to be

participation on the part of the patient population. The following is a

list of studies being conducted by members of AFFTER's Medical Advisory

Committee that are in need of participants. Please get involved and help

make good things happen!

Researcher

seeking participants for Milnacipran study for fibromyalgia - Rheumatology Associates at

Rush-Presbyterian-St-Luke's Medical Center in Chicago.

IL:

Dr. Katz, Rheumatologist and

Researcher is seeking participants for a drug trial on the new medication

called Milnacipran. It has been approved to treat depression in other

countries, and appears to be successful in treating fibromyalgia. If approved,

this would be the first FDA approved medication for fibromyalgia, except

possibly Flexeril. This drug is belongs to a class of drugs called

norepinephrine serotonin reuptake inhibitors (NSRI's) and is now being tested

specifically for use in the treatment of fibromyalgia. This is a national trial

with only a few centers doing this throughout the U.S. For more information,

call Rheumatology Associates at

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

From About.com:

http://chronicfatigue.about.com/b/2007/12/31/new-fda-application-for-fibromyalgia-treatment.htm

Fibromyalgia & CFS

Blog

From Adrienne Dellwo,

Your Guide to Fibromyalgia &

Chronic Fatigue.

FREE Newsletter. Sign Up Now!

About.com

Health's Disease and Condition content is reviewed by Kate Grossman, MD

New FDA

Application for Fibromyalgia Treatment

Milnacipran, a drug new to the U.S.,

is now navigating the FDA process for being approved to treat fibromyalgia

syndrome (FMS). Made by Forest Laboratories, Inc. and Cypress Bioscience, Inc.,

milnacipran is an antidepressant similar to Cymbalta

(duloxetine), which Lilly is trying to get approved for FMS. Both drugs

increase levels of the neurotransmitter serotonin

and the stress hormone norepinephrine, which can be low in people with

fibromyalgia, but milnacipran is the first drug to increase norepinephrine more

than serotonin.

The New Drug Application includes data from two Phase III

trials involving more than two-thousand patients. The company says data show

milnacipran was more effective than a placebo and was well tolerated, with the

majority of side effects described as mild to moderate.

Milnacipran is sold in Europe

under than names Dalcipran and Ixel. has been on the market for a decade and is

approved for depression

in more than 50 countries.

So far, Pfizer's Lyrica

(pregabalin) is the only drug that's FDA approved for fibromyalgia. Cymbalta's

application is pending, but the drug hit a snag in Phase

III clinical trials, when people taking it didn't have significantly less

pain or better physical function than those taking a placebo.

Shari

Ferbert

President,

AFFTER

Advocates for

Fibromyalgia Funding,

Treatment,

Education and Research

www.affter.org

[Guest guest]

I participated in the clinical trial for Milnacipran. It was very difficult because I had to stop taking all other meds. The first part of the study lasted 6 months and I got no relief whatsoever. It was possible, though, that I was taking a placebo. During the second part of the study, everyone was given Milnacipran; however, we didn't know if we were taking 75 or 100 mg (3x daily). I might have experienced a small change during that stage, but not enough to keep me from being miserable. I was so glad when the study ended and I could get back on some real meds.

Pam

Milnacipran - another FMS drug nearing FDA approval!

Good News…

Milnacipran is in the final stages of clinical trials – it will soon be the next FDA approved medication for FMS! It has been studied for several years specifically for FMS, although it has been approved for other illnesses for some time.

Below is a research update back from February, 2004, when Dr. Katz was recruiting participants for a milnacipran study taking place at his location. At that time, we were thinking this would end up being the first medication to be FDA approved, but Lyrica came in first.

There was a lot of research presented at the ACR meeting in November about Milnacipran studies, and it has a lot of people excited that there will soon be more options for fibromyalgia.

So – for those of you who do not tolerate Lyrica, maybe Milnacipran will work for you!

Happy New Year!

Shari Ferbert

www.AFFTER.org

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

RESEARCH UPDATE – Study participants needed! February, 2004

In order for fibromyalgia and chronic fatigue syndrome to see progress in research, there needs to be participation on the part of the patient population. The following is a list of studies being conducted by members of AFFTER's Medical Advisory Committee that are in need of participants. Please get involved and help make good things happen!

Researcher seeking participants for Milnacipran study for fibromyalgia - Rheumatology Associates at Rush-Presbyterian-St-Luke's Medical Center in Chicago. IL:

Dr. Katz, Rheumatologist and Researcher is seeking participants for a drug trial on the new medication called Milnacipran. It has been approved to treat depression in other countries, and appears to be successful in treating fibromyalgia. If approved, this would be the first FDA approved medication for fibromyalgia, except possibly Flexeril. This drug is belongs to a class of drugs called norepinephrine serotonin reuptake inhibitors (NSRI's) and is now being tested specifically for use in the treatment of fibromyalgia. This is a national trial with only a few centers doing this throughout the U.S. For more information, call Rheumatology Associates at

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

From About.com:

http://chronicfatigue.about.com/b/2007/12/31/new-fda-application-for-fibromyalgia-treatment.htm

Fibromyalgia & CFS Blog

From Adrienne Dellwo,Your Guide to Fibromyalgia & Chronic Fatigue.FREE Newsletter. Sign Up Now!

About.com Health's Disease and Condition content is reviewed by Kate Grossman, MD

New FDA Application for Fibromyalgia Treatment

Milnacipran, a drug new to the U.S., is now navigating the FDA process for being approved to treat fibromyalgia syndrome (FMS). Made by Forest Laboratories, Inc. and Cypress Bioscience, Inc., milnacipran is an antidepressant similar to Cymbalta (duloxetine), which Lilly is trying to get approved for FMS. Both drugs increase levels of the neurotransmitter serotonin and the stress hormone norepinephrine, which can be low in people with fibromyalgia, but milnacipran is the first drug to increase norepinephrine more than serotonin.

The New Drug Application includes data from two Phase III trials involving more than two-thousand patients. The company says data show milnacipran was more effective than a placebo and was well tolerated, with the majority of side effects described as mild to moderate.

Milnacipran is sold in Europe under than names Dalcipran and Ixel. has been on the market for a decade and is approved for depression in more than 50 countries.

So far, Pfizer's Lyrica (pregabalin) is the only drug that's FDA approved for fibromyalgia. Cymbalta's application is pending, but the drug hit a snag in Phase III clinical trials, when people taking it didn't have significantly less pain or better physical function than those taking a placebo.

Shari Ferbert

President, AFFTER

Advocates for Fibromyalgia Funding,

Treatment, Education and Research

www.affter.org

[Guest guest]

Pam, good for you for participating in the trial! I am sorry that it

didnt turn out better for you - but that is the only way we will ever

get any medications approved is if people are willing to try. Having

to give up all other medications is difficult and probably stops many

people from participating in these trials. Since you didnt have a

negative reaction to it, perhaps when it gets approved you will be be

able to use it in combination with another medication (like most of us

need to do) and maybe you would have better results.

Thanks for the input.

Shari Ferbert

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

" Pam Horne " wrote:

>

> I participated in the clinical trial for Milnacipran. It was very

difficult because I had to stop taking all other meds. The first part

of the study lasted 6 months and I got no relief whatsoever. It was

possible, though, that I was taking a placebo. During the second part

of the study, everyone was given Milnacipran; however, we didn't know

if we were taking 75 or 100 mg (3x daily). I might have experienced a

small change during that stage, but not enough to keep me from being

miserable. I was so glad when the study ended and I could get back on

some real meds.

>

> Pam

>

>

>

>