Brexpiprazole: Phase III data

The double-blind, international Phase III Polaris trial in 1,532 patients with MDD who had an inadequate response to monotherapy antidepressant treatments (ADT) showed that adjunctive treatment with 3 mg oral brexpiprazole met the primary endpoint of reducing MADRS total score from baseline to week 6 vs. placebo (placebo-adjusted improvement of 1.95 points, p=0.0079). The 1 mg dose of brexpiprazole led to a placebo-adjusted improvement of 1.3 points on the endpoint (p=0.0737). Both doses of brexpiprazole were well tolerated. The most common adverse events reported included akathisia, weight increase, tremor, somnolence and nasopharyngitis. The trial enrolled MDD patients who had an inadequate response to 1-3 treatment attempts with ADT to receive an additional single-blind ADT for 8 weeks. Patients who still failed to reach an adequate response were then randomized to receive adjunctive treatment with brexpiprazole or placebo for 6 weeks. Data were presented at the American College of Neuropsychopharmacology meeting in Phoenix. ...