Otsuka schizophrenia drug meets targets in clinical trial

Otsuka has reported positive data from a phase III clinical study of its new aripiprazole intramuscular (IM) depot treatment for sufferers of schizophrenia.

An independent monitoring committee (IDMC) has recommended an early termination of the company's 52-week placebo-controlled study of the drug, due to the fact it has already met its pre-determined efficacy criteria seven months ahead of schedule.

The drug is intended as a once-monthly injection-based maintenance therapy for schizophrenia and uses the same compound as the licensed oral treatment Abilify.

Based on the success of this study, Otsuka now hopes to file for regulatory approval of the aripiprazole IM depot treatment during the 2011 fiscal year.

Dr William Carson, president and chief executive officer of Otsuka Pharmaceutical Development and Commercialization, said: "The study successfully achieved its efficacy criteria ahead of schedule. According to the IDMC, the interim efficacy analyses met the pre-specified termination rules of the protocol."

Last month, Otsuka agreed a deal to collaborate with Acucela on the co-development and promotion of a new treatment for glaucoma.