Monday, July 11, 2005

Largest pharmaceutical study ever

Prof. Gerald Maguire pointed me towards Indevus' website. According to him, the company "is currently engaged in the largest pharmaceutical study ever on" PDS.

Here is the extract from the website:
"Pagoclone is a novel member of the cyclopyrrolone class of compounds and acts as a gamma amino butyric acid (GABA) receptor modulator. The Company believes that pagoclone increases the action of GABA, thus reducing excess neuronal activity and alleviating symptoms of anxiety.

We are currently evaluating the clinical and regulatory pathway to study pagoclone in stuttering, as well as the commercial opportunity in the U.S and in Europe. In the course of previous clinical trials for generalized anxiety disorder and panic disorder with pagoclone, we observed three patients who entered these trials with a secondary diagnosis of stuttering. These patients were noted to have a dramatic reduction in stuttering while receiving pagoclone. On discontinuation of study drug, stuttering returned to positive levels. These patients represented a small sample of the study and additional testing is necessary to determine whether pagoclone would be effective among a larger group of patients who stutter. A new method of use patent was recently granted to the Company in the U.S. covering the use of pagoclone as a therapeutic agent for stuttering.

We are contemplating initiating a Phase II study in stuttering during 2005 pending future evaluation of clinical, regulatory and commercial factors. Given the substantial preclinical, clinical, regulatory and manufacturing database that has been generated by us, our licensor, Aventis, and our former partners, Warner-Lambert and Pfizer, we believe pagoclone is a highly leveraged commercial opportunity. Should it be demonstrated to be safe and effective in stuttering, we believe we could form a specialty sales force that could successfully introduce the product to pediatric and adult neurologists in the U.S. We expect to seek a partner to commercialize the product outside the U.S.

Stuttering is defined as a break in the flow of speech which is disrupted by repetitions, prolongations or abnormal stoppages of sounds and syllables. It can be accompanied by unusual facial and body movements. Three million Americans suffer with stuttering, the cause of which is unknown. Currently, there is no approved pharmacotherapy for stuttering. The only approved treatment is speech therapy, encompassing physical, psychological and nutritional components." (Source Indevus, taken from their website on July 11th, 2005)

91 comments:

Josh said...

I appreciate your information on speech therapy. I just bookmarked your site and will be back regulalry to keep on top of it. Please check out my blog on speech therapy exposed - I'd really appreciate it

Anonymous said...

I am suffring from stuttring I am ready to be one of the volunteers to try your medecine after the second phase trial I have ferforme RELAXATIO BIO FEEDBACK THERAPY CBT but with no success only XANAX helps me for a short time I am Ph.D Archetect 60 years

Anonymous said...

Tom, I am very interested in participating in a trial. I have looked at the selection criterion and I meet all the requirements. Where can I find information of a trial I could join? are there anyone in the U.S?
my email gabbiano7070@hotmail.com

Anonymous said...

i suffer from stuttering.. I´ll be willing to take the medicine... urgently.... i just want to know what can i do to buy pagoclone. my email adrees is salemmutiara@hotmail.com

cka1234 said...

I am a lifelong stutterer...I am in desparate need of relief...Therapy is a joke...If anything, it has made me worse...Pagoclone sounds like something I would love to try...When will it become available to the general public...If need be, I am willing to be a test subject inoder to have access to this drug...my email address is tomcarter1970@yahoo.com...Please let me know what is the status with pagoclone...

Anonymous said...

Two of my 3 children stutter and have since childhoon. My son is much worse than my daughter and can not speak on the phone at all. He is desperate for some type of help and this drup could be his lifesaver! Please let he know if there is a chance he could be in on one of the trials in the near future. My son is 26 and stuttering has really affected his self esteem. My email is lynda1198@aol.com

Anonymous said...

Can someone email me where i buy progolone form to online. I need it bad i am a stutter and hate it i have trouble talking in groups and even with friends please email me some info quick my email is redskin1845@yahoo.com

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