Schizophrenia study stopped early due to success

Because of successfully meeting efficacy criteria at a protocol-specified interim analysis, an independent data monitoring committee (IDMC) has recommended the early termination of Otsuka’s phase 3, 52-week, placebo-controlled, intramuscular depot aripiprazole trial.

The Aripiprazole Intramuscular Depot Study in Schizophrenia-U.S., evaluated the efficacy and safety of this investigational once-monthly IM depot formulation for the maintenance treatment of schizophrenia.

Aripiprazole intramuscular (IM) depot is a new formulation of Abilify that offers a once-monthly treatment and potentially, easier compliance for schizophrenia patients who must be on life-long therapy.

“If FDA approves this new formulation, it will be a new treatment option for patients with schizophrenia who have issues with compliance,” Robert McQuade, PhD, senior vice president, global medical and regulatory affairs, Otsuka Pharmaceutical Development & Commercialization Inc., told Formulary.

The US registrational study was a multicenter, randomized, double-blind, placebo-controlled study and originally scheduled for a duration of 52 weeks. The study incorporated 2 interim analyses, at 50% and 75% of the 125 events needed to complete the study. It was determined that 50% of the events were achieved in June, 7 months ahead of schedule, and the IDMC determined that the interim analysis met the established termination criteria and recommended that the study be stopped.

Based on the successful interim analysis, Otsuka anticipates filing a New Drug Application during fiscal year 2011.