Teva Reports Positive Top-Line Data From Second Phase III Study Of SD-809

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(RTTNews.com) - Teva Pharmaceutical Industries Ltd. ( TEVA ) announced SD-809 (deutetrabenazine) showed statistically significant results in the second Phase III registration trial studying the potential of SD-809 for the treatment of tardive dyskinesia. In the AIM-TD trial, the primary endpoint was change in Abnormal Involuntary Movement Scale (AIMS) score from baseline to week 12 for three fixed doses of SD-809 as compared to placebo. Patients' abnormal movements were assessed by blinded central video rating. All doses improved AIMS scores compared to placebo and at week 12, the 24 mg and 36 mg dose groups of SD-809 demonstrated a significant change from baseline based on the modified intent-to-treat population.

The company said, during the 12-week treatment, SD-809 demonstrated a favorable safety and tolerability profile. The safety profile of SD-809 was consistent with data from previously reported clinical trials.

The U.S. FDA granted Breakthrough Therapy Designation for SD-809 for the treatment of tardive dyskinesia in November 2015. Teva expects to make a regulatory submission to the FDA by the end of 2016.

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