OPC 34712 filed with FDA for Schizophrenia and MDD-Otsuka/Lundbeck

Otsuka and Lundbeck have announced the submission of a New Drug Application (NDA) to the FDA for OPC 34712 (brexpiprazole) for the treatment of Schizophrenia and as adjunctive treatment of Major Depressive Disorder (MDD). The clinical development program included data from more than 6,500 participants of whom more than 5,300 received brexpiprazole. Data was presented in January 2014, showing statistically significant improvements in mean MADRS total score for patients receiving adjunctive brexpiprazole compared with placebo and a statistically significant advantage over placebo on all secondary endpoints.

Following the submission the FDA will determine if the NDA is sufficiently complete to allow for a substantive review of the data; a decision from the FDA on initiation of the substantive review is expected in September 2014.