FDA Approves Otsuka, Lundbeck NDA For Schizophrenia Drug
By Lori Clapper
The U.S. Food and Drug Administration (FDA) has accepted for review Otsuka Pharmaceutical’s and Lundbeck’s new drug application (NDA) for brexpiprazole as monotherapy in adult patients with schizophrenia and as an adjunctive treatment of major depressive disorder (MDD). The companies expect the regulatory agency to make a decision by early July, 2015.
The NDA nod was based on seven completed placebo-controlled clinical phase 2or 3 studies in the following indications, three of which examined the drug’s effect on schizophrenia. The other four investigated the drug’s role as an adjunctive therapy in MDD. The resulting data was gleaned from 6,000 total participants, with 5,000 receiving brexpiprazole. Across the four studies, more than 3,900 patients entered the prospective phase and more than 1,800 patients were included in the randomized phase of the studies, according to a company press release. In both indications, patients taking brexpiprazole saw improvements in schizophrenia MDD symptoms; however, the drug did not see statistical separation from placebo in the schizophrenia trials.
In the studies, 8.1 percent of patients discontinued use due to adverse side effects as compared to 12.7 percent of patients receiving the placebo. Research confirmed that the only adverse event that occurred in more than five percent of brexpiprazole patients was akathisia, a common side effect causing an inner restlessness or urge to constantly move (5.8 percent vs. 4.5 percent).
“We and our collaborator Lundbeck are proud to have reached this juncture in the development of brexpiprazole,” William H. Carson, M.D., president and CEO of Otsuka Pharmaceutical Development & Commercialization, said. “In view of the importance of good mental health and the projected impact of mental health disorders on people affected, their families, and society, future new treatment options will be indispensable.”
“We are proud to have completed an extensive clinical program studying the safety and efficacy of brexpiprazole in adults with schizophrenia and those with MDD,” said Anders Gersel Pedersen, EVP and head of R&D in Lundbeck. “We believe in the potential of brexpiprazole to fulfill unmet patient needs and look forward to working with the FDA throughout the NDA review.”