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)