Successful second Phase III(AIM-TD) trial for SD 809 (deutetrabenazine) for tardive dyskinesia .- Teva

Teva Pharmaceutical Industries Ltd.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 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.

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. At week 12, the AIMS rating improved from baseline by -3.3 points for 36 mg (P=0.001), -3.2 points for 24 mg (P=0.003) and -2.1 for 12 mg (P=NS), compared to -1.4 in placebo. In addition to the primary endpoint, mean scores on the Clinical Global Impression of Change (CGI) improved by -0.5 for 36 mg (P=0.011) and by -0.6 for 24 mg (P=0.002) based on the modified intent-to-treat population. The CGI is a global assessment of the patient�s abnormal movements made by the treating investigator. For the protocol-specified secondary endpoint of CGI, in which treatment success was defined as �much improved� or �very much improved� at Week 12 and missing data were counted as treatment failure, 24 mg was superior to placebo (P=0.014); the 36 mg dose was superior to placebo, but did not reach statistical significance (P=0.059). Teva will present a fuller analysis at a future medical meeting.