Top-line data from a Phase 3 clinical trial, AIM-TD, assessing Teva Pharmaceutical Industries' (NASDAQ:TEVA) SD-809 (deutetrabenazine) for the treatment of tardive dyskinesia (TD) showed a statistically valid treatment benefit. The positive data follow successful results from an earlier Phase 3, ARM-TD, announced in June 2015. The company plans to file a New Drug Application (NDA) in the U.S. by year end.
The primary endpoint was the reduction in involuntary movements versus placebo as measured by the Abnormal Involuntary Movement Scale (AIMS) from baseline to Week 12 for three fixed doses of SD-809 (12 mg, 24 mg and 36 mg tablets titrated for four weeks to the targeted randomized dose then maintained for eight weeks). Placebo tablets were administered twice daily for 12 weeks.
At Week 12, the improvements in AIMS scores for 12 mg, 24 mg, 36 mg and placebo were -2.1, -3.2, -3.3 and -1.4, respectively. All were statistically significantly greater than placebo except the 12 mg dose. The 24 mg and 36 mg doses also demonstrated superiority to placebo as measured by the Clinical Global Impression of Change (CGI), an investigator-generated metric. Complete data will be presented at a future medical conference.
SD-809 is an orally available small molecule inhibitor of vesicular monoamine 2 transporter (VMAT2) that is designed to regulate the levels of the neurotransporter dopamine in the brain.
TD is a difficult-to-treat neurological disorder characterized by involuntary repetitive body movements. It commonly occurs in patients on long-term high-dose antipsychotic drugs.
Previously: Teva's SD-809 successful in mid-stage study in movement disorder (June 16, 2015)
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