Indevus announces positive top line results in phase 2 study of pagoclone in stuttering

By Lisa Kerner

Erie, Pa., May 24 - Indevus Pharmaceuticals, Inc. said top line results from its phase 2 clinical trial (Express) for pagoclone in persistent developmental stuttering show that pagoclone produces a statistically significant benefit in primary and secondary endpoints compared to a placebo.

A novel, non-benzodiazepine, GABA-A selective receptor modulator, pagoclone enhances GABA circuit activity, restoring more normal function in speech areas of the brain, according to a company news release.

The primary endpoints were evaluated using the Frequency and Duration Subscale of the Stuttering Severity Instrument Version 3, the Stuttering Severity Scale and the Subjective Screening of Stuttering Severity Subscore.

Secondary endpoints were measured using the Clinician Global Impression-Improvement, the Liebowitz Social Anxiety Scale and the Speech Naturalness Scale.

A total of 132 patients were randomized in the eight-week, placebo-controlled, double-blind, multi-center trial. Eighty-eight patients received escalating doses of pagoclone (0.3 mg to 0.6 mg) per day, while 44 patients received a placebo. The patient population, 79% male, was reflective of stuttering's gender distribution, the company said.

Pagoclone was well tolerated and not associated with any serious adverse events.

About 90% of patients continued into the open-label phase of the study in which all patients receive pagoclone.

Patients initially randomized to pagoclone have continued to show improvement, while those initially randomized to a placebo are also exhibiting improvement in their condition.

"This study was designed as an exploratory trial to follow up on a limited number of observations of the effect of pagoclone on stuttering during previous anxiety trials," chairman, president and chief executive officer Glenn L. Cooper said in the release.

"The design of the Express trial enabled us to evaluate the condition from several clinical perspectives and we believe this provides us with a strong foundation to develop a clinical plan for further development."

About 1% of the adult population is afflicted with stuttering, with more than four times as many males affected as females. The exact cause of stuttering is unknown, and there is no FDA-approved medication available to treat the disorder.

The top line data will be presented next month at the National Stuttering Association's 23rd Annual Conference in Long Beach, Calif., and at a meeting of the International Fluency Association in July in Dublin, Ireland.

Indevus develops products targeting urology, gynecology and men's health.

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