Results from a multicenter study evaluating the effects of the investigational compound brexpiprazole as monotherapy in adult patients with schizophrenia recently were published online by the American Journal of Psychiatry.
Brexpiprazole is an investigational psychotropic compound discovered by Otsuka Pharmaceutical, Co., Ltd. and under co-development with Lundbeck.
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.
The Phase III trial randomized 636 patients with acute schizophrenia to fixed doses of brexpiprazole or a placebo respectively, for six weeks. The results indicated that brexpiprazole 2 mg and 4 mg demonstrated significant improvement versus a placebo over the six-week period.
Otsuka and Lundbeck initially presented results from this Phase III study at the 53rd Annual Meeting of the American College of Neuropsychopharmacology (ACNP) in December 2014. A new drug application for brexpiprazole has been filed with the U.S. Food and Drug Administration (FDA) and the PDUFA date is July 2015.