Teva Announces Publication Of Results From Phase III Study AIM-TD

(RTTNews) - Teva Pharmaceutical Industries Ltd. (TEVA) announced the publication of results from the Phase III study, AIM-TD (Addressing Involuntary Movements in Tardive Dyskinesia), in the medical journal, The Lancet Psychiatry.

The AIM-TD study evaluated the safety, efficacy and tolerability of the investigational use of fixed-dose deutetrabenazine (SD-809) compared to placebo for the treatment of tardive dyskinesia (TD).

TD is a chronic condition that affects patients who are suffering from primary psychiatric illnesses, which are already debilitating and can be socially isolating.

AIM-TD was a Phase III, randomized, double-blind, placebo-controlled, parallel group, fixed-dose study that evaluated 222 male and female adults with moderate to severe TD. All patients had a total motor Abnormal Involuntary Movement Scale (AIMS) = 6 at screening and were randomized at baseline in a 1:1:1:1 ratio to receive one of three fixed-dose regimens of deutetrabenazine (12 mg/day, 24 mg/day, or 36 mg/day) or placebo. Patients underwent dose escalation during the initial 4 weeks, followed by an 8-week maintenance period and a 1-week washout.