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  5. New Drug Application for Otsuka's Once-monthly Aripiprazole Depot Formulation for Maitenance Treatment of Adult Patients With Schizophrenia Accepted for Review by the U.S. Food and Drug Administration

November 22, 2011

Otsuka Pharmaceutical Co., Ltd.
H. Lundbeck A/S

Pharmaceuticals

New Drug Application for Otsuka's Once-monthly Aripiprazole Depot Formulation for Maitenance Treatment of Adult Patients With Schizophrenia Accepted for Review by the U.S. Food and Drug Administration

Submission based on data from pivotal trials evaluating efficacy, safety and tolerability in patients suffering from schizophrenia

TOKYO, JAPAN and COPENHAGEN, DENMARK, November 22, 2011 -- 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."

About Schizophrenia

Schizophrenia is a disease characterized by a distortion in the process of thinking and of emotional responsiveness. It most commonly manifests as auditory hallucinations, paranoid or bizarre delusions, or disorganized speech and thinking, and is accompanied by significant social or occupational dysfunction. Onset of symptoms typically occurs in young adulthood and is a chronic condition that often requires life-long treatment to mitigate symptoms. It has been estimated that schizophrenia affects approximately 1% of the adult population in the U.S. and Europe. In the U.S., there are approximately 2.2 million adults with schizophrenia, prevalent equally in both genders.*1

  • *1 Source: National Institute of Mental Health

About Aripiprazole Depot Formulation

Aripiprazole depot formulation is a sterile lyophilized cake that when reconstituted with sterile water for injection forms an injectable suspension. This formulation was studied as a once-monthly injection for the maintenance treatment of schizophrenia. In October, 2010, Otsuka announced that the Phase III U.S. registrational study, a multicenter, randomized, double-blind, placebo-controlled study, was terminated early by an Independent Data Monitoring Committee due to meeting efficacy criteria at a protocol-specified interim analysis.


Information in this news release was current as of the original release date.

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