Phase II Clinical Trials Indicate Pagoclone May Treat Stuttering

Filed in archive Diagnostics, Methodologies and Instrumentation , Drugs, Vaccines and Therapeutics , Meetings and Other Events on May 31, 2006

Indevus Pharmaceuticals, Inc. announced favorable results from its Phase II clinical trials for pagoclone in persistent developmental stuttering, a communication disorder characterized by sppech broken by syllable repetitions or consonant prolongations. It may occur as a result of genetics, neurophysiology, and social anxiety, or from a combination of any of these factors. It affects approximately 1% of the population, or about 3 million cases in the US, and is 4 times more prevalent in males, than females.

What is Pagoclone? Pagoclone is a novel, non-benzodiazepine, GABA-A selective receptor modulator. Its exact mechanism of action is unknown, although GABA is believed to be an important neurotransmitter in the brain that may be disrupted in people who stutter.

The trials conducted were evaluated using these validated measures and endpoints:
Frequency and duration Subscale of the Stuttering Severity Instrument Version 3 (SSI-3)
Stuttering Severity Scale (SEV)
Subjective Screening of Stuttering (SSS) Severity Subscore
Clinician Global Impression-Improvement (CGI-I)
the Liebowitz Social Anxiety Scale (LSAS) and the
Speech Naturalness Scale (SNS)

Improved severity of stuttering and social anxiety indicate that pagoclone may be a potential treatment for stuttering. A replay of a conference call discussing the results will be available until June 23, 2006. To access the replay, please dial 888-286-8010 from the U.S. and Canada, and 617-801-6888 from international locations, using the passcode 93985986. Details of the study will also be presented at the 5th World Congress of Fluency Disorders on July 27, 2006 in Dublin, Ireland.