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Indevus Announces Presentation of Pagoclone Data at 47th Annual New,Clinical Drug Evaluation Unit Meeting

placebo, demonstrated continued improvement, achieving approximately a 20 point mean decrease over the five month period.

Pagoclone was shown to be safe and well-tolerated. There were no serious adverse events associated with pagoclone. The most commonly reported side effects associated with pagoclone were headache (12.5% for pagoclone and 6.8% for placebo) and fatigue (8% for pagoclone and 0% for placebo). As with all prior trials for pagoclone, reports of somnolence and sedation were similar between pagoclone and placebo. Additionally, pagoclone exerted its clinical effect on patients without disrupting the naturalness of their speech as assessed by the SNS, a validated 9-point scale.

Pagoclone has continued to demonstrate a very favorable safety profile during the open label phase.

About Stuttering

Nearly 3 million Americans, or as much as 1% of the population, are afflicted with persistent stuttering, with approximately 4 times as many males being affected by the condition as females. Stuttering is a DSM-IV-TR Axis I disorder and is characterized by symptoms in which the flow of speech is disrupted by prolongations, repetitions, and blocks of sounds, syllables, words or phrases. The exact cause of stuttering is unknown; however, emerging evidence has shown that this disorder is associated with abnormalities in brain areas related to speech motor control. Stuttering most often begins in early childhood. It often persists into adulthood and this form is classified as persistent developmental stuttering. Given the importance of communication in daily life, stuttering impairs an individual's academic, social and occupational functioning. No medication is FDA approved for stuttering and the most commonly utilized treatment is speech therapy.

About pagoclone

Pagoclone is a novel, non-benzodiazepine, GABA-A selective receptor modulator. It is part of a new chemical class of agents and lacks many of the common benzodiazepine si
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