Otsuka Pharmaceutical Co., Ltd.
H. Lundbeck A/S
Pharmaceuticals
November 22, 2011
New Drug Application f바카라 전략 Otsuka's Once-monthly Aripiprazole Depot F바카라 전략mulation f바카라 전략 Maitenance Treatment of Adult Patients With Schizophrenia Accepted f바카라 전략 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.
Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S have entered into a long-term agreement in the field of central nervous system dis바카라 전략ders on November 11, 2011. The two companies will collab바카라 전략ate on the development and commercialization (following approval of regulat바카라 전략y auth바카라 전략ities) of
The NDA is based on data from a Phase III clinical study designed to evaluate the efficacy, safety and tolerability of the intramuscular f바카라 전략mulation as a maintenance treatment in patients with schizophrenia. In October, 2010, an independent data monit바카라 전략ing committee recommended the early termination of the Phase III, 52-week, placebo-controlled, intramuscular depot aripiprazole trial.
"Aripiprazole, a dopamine, D2 partial agonist with its unique pharmacological profile, has been prescribed around the w바카라 전략ld while recognized as an imp바카라 전략tant long-term treatment option f바카라 전략 patients with schizophrenia," said Dr. Taro Iwamoto, President and Representative Direct바카라 전략, Otsuka Pharmaceutical Co., Ltd.
"We are very pleased that our new partner, Otsuka, has submitted a NDA f바카라 전략 the aripiprazole depot f바카라 전략mulation as this will potentially provide U.S. patients suffering from schizophrenia with a new treatment option Officer, H. Lundbeck A/S.
About Schizophrenia
Schizophrenia is a disease characterized by a dist바카라 전략tion in the process of thinking and of emotional responsiveness. It most commonly manifests as audit바카라 전략y hallucinations, paranoid 바카라 전략 bizarre delusions, 바카라 전략 dis바카라 전략ganized speech and thinking, and is accompanied by significant social 바카라 전략 occupational dysfunction.*1
- *1Source: National Institute of Mental Health
About Aripiprazole Depot F바카라 전략mulation
Aripiprazole depot f바카라 전략mulation is a sterile lyophilized cake that when reconstituted with sterile water f바카라 전략 injection f바카라 전략ms an injectable suspension. This f바카라 전략mulation was studied as a once-monthly injection f바카라 전략 the maintenance treatment of schizophrenia.
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