Brexpiprazole: Phase III data

The double-blind, international Phase III Pyxis trial in 824 patients with MDD who had an inadequate response to monotherapy antidepressant treatments (ADT) showed that adjunctive treatment with 2 mg oral brexpiprazole met the primary endpoint of reducing MADRS total score from baseline to week 6 vs. placebo (placebo-adjusted improvement of 3.21 points, p=0.0002). Brexpiprazole was 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. ...