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

or worsened." Pagoclone produced numerically superior improvement at week 2 (p=.20) and statistically significant improvement at week 4 (p=.007) and at week 8 (p=.02) as compared to placebo. At week 8, 55% of pagoclone treated patients were improved compared to 36% of placebo treated patients. Open label data showed considerable gains after three months of open label treatment. For patients receiving placebo during the double blind phase, 36% were rated as improved, but following 3 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 3 additional months of open label treatment, 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.

The LSAS, measured at week 4 and week 8, is a validated measure of social anxiety symptoms. Stuttering is often co-morbid with symptoms of social anxiety which can be a disabling consequence of stuttering. Although patients with primary anxiety disorders were excluded from participating in the trial, pagoclone produced a trend for significant improvement in social anxiety symptoms (total LSAS score) compared to placebo at week 4 (p=.09) and week 8 (p=.07). On a subscale comprised of the elements of the LSAS that evaluate anxiety-provoking speaking situations, pagoclone produced statistically significant improvement at both week 4 (p=.02) and week 8 (p=.02). 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 LSAS. Patients treated with pagoclone demonstrated statistically significant improvements in the LSAS Total scale compared with placebo. During the open label extension, both groups, those receiving active pagoclone as well as those receiving
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