Brexpiprazole: Phase III data

The double-blind, international Phase III BEACON trial in 674 patients with acute schizophrenia showed that once-daily 4 mg oral brexpiprazole met the primary endpoint of reducing PANSS total score from baseline to week 6 vs. placebo (20 vs. 13.5 points, p=0.0022). PANSS total score was reduced from baseline to week 6 by 16.9 points at the 1 mg brexpiprazole dose and by 16.6 points at the 2 mg brexpiprazole dose (p=0.1588 and p=0.1448, respectively). High-dose brexpiprazole also met the secondary endpoint of reducing CGI-S score from baseline to week 6 vs. placebo (1.2 vs. 0.8 points, p=0.0015). CGI-S score was reduced by 0.9 points at the 1 mg brexpiprazole dose and by 1 point at the 2 mg brexpiprazole dose (p>0.05 for both). All doses of brexpiprazole were well tolerated. The most common treatment-emergent adverse events reported were dyspepsia, insomnia and agitation. Data were presented at the American College of Neuropsychopharmacology meeting in Phoenix. ...