INDEVUS INITIATES PHASE II TRIAL OF STUTTERING DRUG

Indevus Pharmaceuticals has initiated a Phase II trial of pagoclone in patients with persistent developmental stuttering.

The trial is being conducted in 120 adults at 16 investigational sites in the U.S. Assessments in the trial include standard measures of speech fluency, as well as ancillary measures to evaluate disability and quality of life of the enrolled stuttering patients. In a subset of the clinical centers, functional brain imaging assessments will be collected as potential biomarkers of the effects of pagoclone -- a non-benzodiazepine, selective GABA-A receptor agonist -- in the treatment of stuttering. At present, there is no FDA-approved pharmacotherapy for stuttering.

According to the National Stuttering Association (NSA), stuttering is defined as a communication disorder involving disruptions, or "disfluencies," in a person's speech. There evidence that stuttering is a neurologic, rather than a primary psychological disorder, that affects areas of the brain concerned with hearing and speech. Studies have revealed that seemingly mild stuttering may still have significant long-term psychological and social consequences.