Alkermes announced results from its Phase 3 trial of aripiprazole lauroxil, an investigational drug for the treatment of schizophrenia. Aripiprazole lauroxil is an injectable atypical antipsychotic with one-month and two-month formulations that converts to aripiprazole once in the body.
The multicenter, double-blind, placebo-controlled study was designed to assess the efficacy, safety, and tolerability of aripiprazole lauroxil in patients experiencing acute exacerbation of schizophrenia.
Patients (n=623) were randomly assigned to receive once-monthly IM injections of aripiprazole lauroxil 441mg, aripiprazole lauroxil 882mg or a matching placebo injection of either high volume or low volume for 12 weeks. The primary efficacy endpoint of the study was the mean change from baseline at Week 12 in Positive and Negative Syndrome Scale (PANSS) total score.
All participants in the double-blind portion of the study were eligible to continue in an open-label phase and receive aripiprazole lauroxil for an additional 12 months. The objective of the extension phase of the study is to assess the safety and long-term durability of effect of once-monthly aripiprazole lauroxil.
The primary endpoint was met with statistically and clinically significant reductions PANSS scores. During the 12-week, double-blind treatment period, patients treated once-monthly with either 441 mg or 882 mg of aripiprazole lauroxil demonstrated statistically and clinically significant placebo-adjusted mean reductions from baseline in PANSS total scores (-10.9 points, P<0.001 for aripiprazole lauroxil 441mg; and -11.9 points, P<0.001 for aripiprazole lauroxil 882mg).
The company plans to submit a New Drug Application (NDA) to the FDA in the third quarter of 2014.
This article originally appeared on MPR