NDA for aripiprazole depot formulation for maintenance treatment of adult patients with schizophrenia accepted

Posted: 22 November 2011 | | No comments yet

H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced today that the US Food and Drug Administration (FDA) 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 and Lundbeck entered into a long-term CNS agreement for up to five innovative psychiatric and neuroscience products on 11 November 2011. The two companies are collaborating on the co-development and co-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,” says 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 an NDA for the aripiprazole depot formulation as this will potentially provide patients suffering from schizophrenia in the US with a new treatment option,” says Ulf Wiinberg, President & Chief Executive Officer at Lundbeck, and continues: “Schizophrenia is a serious disease and there is still a great need to offer patients improved maintenance therapies and for therapies that can improve compliance.”

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 US and Europe. In the US, there are approximately 2.2 million adults with schizophrenia, prevalent equally in both genders[1].

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 US registration study, a multicenter, randomized, double-blind, placebo-controlled study, was terminated early by an Independent Data Monitoring Committee following meeting efficacy criteria at a protocol-specified interim analysis.


  1. Source: National Institute of Mental Health