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

stuttering as measured by the SSI-3 scale when compared to placebo (p=.02). While receiving 8 weeks of placebo, patients had experienced a mean reduction of approximately 5% in the percentage of syllables stuttered, however after three months of open label treatment, patients achieved a reduction of 31%. These open label gains lagged slightly the gains made by patients originally randomized to 8 weeks of active pagoclone (5 months total exposure), who had, during the double blind phase, experienced a mean reduction of 18% of syllables stuttered and then went on to achieve a reduction of 40% of syllables stuttered after three months of the open label extension.

The SEV, measured at week 2, week 4 and week 8, is a validated measure of stuttering. The SEV is a 9-point, clinician rated severity scale anchored by "no stuttering" and "extremely severe stuttering." The on-treatment effect of patients receiving pagoclone demonstrated a numerically superior rating versus patients treated with placebo (p=.18).

The SSS Severity Subscore, measured at week 2, week 4 and week 8, is a validated, patient-rated assessment of stuttering that takes into account specific speaking situations that have taken place over the prior week. Pagoclone produced a statistically significant reduction at week 2 (p=.004) and week 4 (p=.05) and a trend for significant improvement at week 8 (p=.08) as compared to placebo.

The secondary endpoints evaluated in the study included the Clinician Global Impression-Improvement (CGI-I), the Liebowitz Social Anxiety Scale (LSAS) and the Speech Naturalness Scale (SNS).

The CGI-I, measured at week 2, week 4 and week 8, is a 7-point, validated and widely accepted clinician-rated measure of improvement as compared to baseline, considering all sources of available clinical information about the patient. For analysis of the improvement in the severity of stuttering, patients were categorized as having either "improved" versus "no change
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