Otsuka and H. Lundbeck announced that the FDA has accepted for review its New Drug Application (NDA) for once-monthly aripiprazole depot formulation for the maintenance treatment of schizophrenia in adults. The NDA is based on data from a Phase 3 clinical study designed to evaluate the efficacy, safety and tolerability of the intramuscular formulation as a maintenance treatment in patients with schizophrenia.
In October 2010, an independent data-monitoring committee recommended the early termination of the 52-week, placebo-controlled, intramuscular depot aripiprazole trial. This was due to the study successfully meeting efficacy criteria at a protocol-specified interim analysis.
Aripiprazole depot formulation is a sterile lyophilized cake that when reconstituted with sterile water for injection forms an injectable suspension.
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