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

n the open label portion of the study, these same patients experienced a 31% mean reduction. These open label gains lagged slightly the gains made by patients originally randomized to 8 weeks of active pagoclone (5 months total exposure). For those patients randomized to pagoclone in the double- blind phase, the mean reduction in percent syllables stuttered was 18%, while in the open label phase, the mean reduction was 40%.

Similarly, data for the Clinician's Global Impression of Improvement (CGI- I) showed considerable gains during the three months of open label treatment. For patients receiving placebo during the double blind phase, 36% were rated as improved, while following three months of open label treatment, 80% were rated as improved. For patients receiving active pagoclone during the double blind phase, 55% had been rated as improved, and following three additional months of open label treatment with pagoclone, 90% were rated as improved. These results indicate that, while the beneficial effects of pagoclone were evident within the 8-week double-blind phase, the magnitude of benefit continued to grow for at least three months. Pagoclone has continued to demonstrate a very favorable safety profile during the open label phase. These results have been submitted for publication to a leading journal in this field.

Additionally, approximately half the patients who participated in the double-blind phase had a high level of social anxiety symptoms pre-treatment, as measured using the Liebowitz Social Anxiety Scale (LSAS). In this high- severity subgroup, pagoclone demonstrated statistically significant improvements in the LSAS Total scale compared with placebo. Both groups, those receiving active pagoclone as well as those receiving placebo, demonstrated continued improvement, achieving over a 20 point mean decrease over the five month period.

Study Design

The Phase II study, known as the EXPRESS trial, was an 8-week, placebo controlled,
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