ARTICLE | Clinical News

Brexpiprazole meets primary in Phase III depression trial

December 11, 2014 3:44 AM UTC

H. Lundbeck A/S (CSE:LUN) and Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) said all three doses of once-daily brexpiprazole ( OPC-34712) met the primary endpoint in two Phase III trials to treat major depressive disorder (MDD).

Brexpiprazole combinations led to statistically significant reductions in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score from baseline to six weeks vs. placebo. In the first study, 2 mg reduced scores by 3.21 points (p=0.0002). In the second, 1 mg reduced scores by 1.30 (p=0.0737) and 3 mg reduced scores by 1.95 (p=0.0079). The trials studied brexpiprazole plus an approved antidepressant therapy (ADT) in a total of 599 patients who had previously had inadequate responses to ADT monotherapy. ...