Re: LDN Website Update December 2004

[Guest guest]

I think it is not difficult to invent a new drug that is a bit

different from Naltrexone but still has the same effect. This drug

would get the same patent protection from FDA as a brand new drug.

(This is a widely used practice for so-called me-too drugs).

The problem is that even if PTI-901 would be approved as a drug, it

would face a generic competitor, Naltrexone. The same thing happened

in case of Claritin, when the patent expired, its producer had a new

drug approved with a similar name, Clarinex. But no one wanted to

switch to a more expensive drug once the generic version was

available (would you pay twice as much for an approved LDN?)

So while I do sympathize with the efforts of Pain Therapeutics, I

think they run a huge business risk.

> As we all know, there is rampant cynicism on the net that the key

> obstacle to getting a trial for LDN & MS is LDN's generic status.

> But, it appears that Pain Theraputics has worked around this

> somehow, as its clear that they are patenting " PTI-901 " for IBS,

> however their press releases describe PTI-901 as " naltrexone

> hydrochloride " . Do you think they have tweaked the molecule

> or reformulated somehow?

>

[Guest guest]

Please note my email address has changed to sbenz@...

-------------- Original message ----------------------

From: " Gluck " <joelg@...>

LDN Website Update December 2004

www.low dose naltrexone.org / www.ldninfo.org

Latest News for December 2004 has been posted on the website, as follows:

Clinical Trials for LDN are Emerging At Long Last. Although, as of

this month, there are yet no published medical reports of a definitive

clinical trial for low dose naltrexone, there are three current

clinical trials in various stages of progress -- for Crohn's disease,

irritable bowel syndrome, and, in Germany, a small trial for MS. In

addition, there are at least five other clinical trials (in five

different countries) that are being planned. Though all the plans may

not come to fruition, we are finally seeing an impressive

international recognition of the efficacy of low dose naltrexone. We

will attempt to regularly update the information on our new linked

page: Clinical Trials for LDN (www.low dose naltrexone.org/ldn_trials.htm).

Dr. Bihari's Foundation Now on the Internet. The Foundation for

Immunologic Research (FFIR), a 501©(3) non-profit organization

founded originally in 1989 by Bernard Bihari, MD and two colleagues as

the Foundation for Integrative Research, now has a page on the

Internet in order to help seek increased funding. It states: " The

purpose of the FFIR has always been to raise money for clinical trials

of the various clinical uses of Low Dose Naltrexone. The cost of

scientific clinical trials, correctly run, can range from half a

million dollars for a small, brief study to the many tens of millions

of dollars. " See the Foundation's website (www.ffir.org).

LDN Website Editors

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