Success in Phase III study of SD 809 for Tardive Dyskinesia- Servier

Teva Pharmaceutical Industries Ltd., announced positive top-line results from the pivotal clinical study Aim to Reduce Movements in Tardive Dyskinesia (ARM-TD) designed to evaluate the efficacy of SD-809 (deutetrabenazine) in the treatment of moderate to severe tardive dyskinesia.

Top-line data showed that the study met its primary endpoint and demonstrated a positive trend in all secondary endpoints. Importantly, the study also showed a favorable safety and tolerability profile, including low rates of depression, somnolence, insomnia and akathisia. The primary endpoint of ARM-TD was the change in the Abnormal Involuntary Movement Scale (AIMS) from baseline to end of therapy, assessed by blinded centralized video rating. The study results show patients taking SD-809 achieved an improvement of 3.0 points on the AIMS score from baseline to end of therapy compared to 1.6 points in placebo (p = 0.0188) for a clinically meaningful effect. Study results also demonstrated a favorable safety and tolerability profile of SD-809. Fewer patients taking SD-809 than placebo experienced serious adverse events (SAEs) Three patients discontinued from the study for adverse events (1 in SD-809 group vs. 2 in placebo group). For all other side effects reported in the study, rates in the SD-809 group were similar or lower than the placebo group. Further analysis of the additional data from the study is ongoing and details will be shared at future medical meetings and through peer-reviewed publication.