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ARTICLE | Clinical News

Teva's SD-809 passes latest tardive dyskinesia test

September 22, 2016 7:00 AM UTC

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) said two doses of SD-809 deutetrabenazine met the primary endpoint in the Phase III AIM-TD study to treat moderate to severe tardive dyskinesia. The company intends to submit an NDA to FDA for SD-809 by year end.

The 288-patient trial evaluated 12, 24 and 36 mg doses of SD-809 vs. placebo, and measured improvements in Abnormal Involuntary Movement Scale (AIMS) from baseline to 12 weeks. The high and middle doses improved baseline scores by 3.3 and 3.2 points, respectively, vs. 1.4 points for placebo (p=0.001 for the high dose and p=0.003 for the middle dose). The low dose improved scores by 2.1 points, which was non-significant vs. placebo. ...