FDA accepts Otsuka's aripiprazole depot formulation NDA for review

Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announced today that the U.S. Food and Drug Administration has determined that a new drug application (NDA) for Otsuka's investigational once-monthly aripiprazole depot formulation for the indication of maintenance treatment of schizophrenia in adults is sufficiently complete to permit a substantive review.

Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S have entered into a long-term agreement in the field of central nervous system disorders on November 11, 2011. The two companies will collaborate on the development and commercialization (following approval of regulatory authorities) of aripiprazole depot formulation worldwide.

The NDA is based on data from a Phase III 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 Phase III, 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, a dopamine, D₂ partial agonist with its unique pharmacological profile, has been prescribed around the world while recognized as an important long-term treatment option for patients with schizophrenia," said Dr. Taro Iwamoto, President and Representative Director, Otsuka Pharmaceutical Co., Ltd. "The submission of this NDA for the once monthly aripiprazole depot formulation is the first step in providing another treatment option for the current problems faced by patients with schizophrenia."

"We are very pleased that our new partner, Otsuka, has submitted a NDA for the aripiprazole depot formulation as this will potentially provide U.S. patients suffering from schizophrenia with a new treatment option," said Ulf Wiinberg, President and Chief Executive Officer, H. Lundbeck A/S. "Schizophrenia is a serious disease and there is still a great need for improved maintenance therapies to offer patients."