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pharmiweb.com today | 25 September 2016

Teva Announces Positive Top-Line Data from Second Phase III Study of SD-809 in Tardive Dyskinesia (TD)

Teva Pharmaceutical Industries Ltd. today 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 (TD). These new results for the AIM-TD trial follow positive results from the ARM-TD trial announced in June 2015. Both ARM-TD and AIM-TD were 12 week treatment studies. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for SD-809 for the treatment of TD in November 2015. Teva expects to make a regulatory submission to the FDA by the end of 2016....

“We are delighted to deliver positive results from a second Phase III study showing the potential for SD-809 to treat the involuntary movements of tardive dyskinesia. This condition is debilitating and often leads to isolation of those affected,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva, adding that “The study results strengthen our resolve to making this product an option for those patients in need. We are grateful to the trial participants and study investigators who contributed to this study.”

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.

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