Phase III Study of Brexpiprazole in Adult Patients with Schizophrenia Published in American Journal of Psychiatry


Results from a multicenter study evaluating the effects of the investigational compound brexpiprazole as monotherapy in adult patients with schizophrenia were published today online by the American Journal of Psychiatry.

The study “Efficacy and Safety of Brexpiprazole for the Treatment of Acute Schizophrenia: A 6-Week Randomized Double-Blind Placebo-Controlled Trial” evaluated the efficacy and tolerability of brexpiprazole in adult patients with an acute exacerbation of schizophrenia. The results will be featured in the September 2015 print issue of the publication.

Study Results

The Phase III trial randomized 636 patients with acute schizophrenia to fixed doses of brexpiprazole (0.25 mg 2 mg or 4 mg) or placebo (randomized 1:2:2:2) respectively for 6 weeks.i The results indicated that brexpiprazole 2 mg and 4 mg demonstrated significant improvement versus placebo in the primary endpoint of change from baseline to Week 6 in PANSS (Positive and Negative Syndrome Scale) Total Score (0.25 mg: -14.90; 2 mg: -20.73 p=<0.0001; 4 mg: -19.65 p=0.0006 vs. placebo -12.01). i


or here:


Is it really that good?

FDA Approves Otsuka and Lundbeck’s REXULTI (Brexpiprazole)