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Positive Results Reported From Pivotal Phase III Study of Aripiprazole Lauroxil for Treatment of Schizophrenia

Once-monthly injection achieves primary and secondary endpoints

Positive results have been reported from a randomized, double-blind, placebo-controlled phase III clinical trial of injectable aripiprazole lauroxil (Alkermes PLC) in patients with schizophrenia.

Patients treated once monthly with either 441 mg or 882 mg of aripiprazole lauroxil demonstrated statistically significant reductions from baseline in Positive and Negative Syndrome Scale (PANSS) total scores at week 12 compared with placebo (P < 0.001 for both aripiprazole lauroxil 441 mg and aripiprazole lauroxil 882 mg), which was the study’s primary endpoint.

Based on the positive results from this phase III trial, a new drug application (NDA) is expected to be submitted to the FDA in the third quarter of 2014.

Aripiprazole lauroxil is a new long-acting injectable antipsychotic agent designed to provide patients with once-monthly dosing of a medication that, once in the body, converts to aripiprazole, a molecule that is commercially available under the trade name Abilify (Otsuka).

Data from the full analysis set showed statistically significant improvement in PANSS total scores from baseline in both aripiprazole lauroxil dose groups compared with the placebo treatment group. In addition to meeting the prespecified primary efficacy endpoint, the study also met the prespecified key secondary endpoint of improvement on the Clinical Global Impression–Improvement (CGI-I) scale versus placebo at week 12 (P < 0.001).

Aripiprazole lauroxil was generally well tolerated, and the drug’s safety profile was similar to that reported with oral aripiprazole. The most common adverse events in the study were insomnia, akathisia, and headache.

The pivotal phase III, randomized, double-blind, placebo-controlled study was designed to assess the efficacy, safety, and tolerability of injectable aripiprazole lauroxil in patients experiencing acute exacerbation of schizophrenia. The trial included adult patients who met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia and had a PANSS total score of 70 or higher at baseline.

A total of 623 patients were randomly assigned to receive once-monthly intramuscular injections of aripiprazole lauroxil 441 mg, aripiprazole lauroxil 882 mg, or placebo for 12 weeks. After randomization, the patients received their first injection along with daily oral study drug for the first 3 weeks. The patients randomly assigned to the two aripiprazole lauroxil treatment groups received oral aripiprazole for those initial 3 weeks, whereas patients assigned to the placebo group received matching oral placebo for 3 weeks.

All of the participants in the double-blind portion of the study are eligible to continue in an open-label phase and to 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 the effect of once-monthly injections of aripiprazole lauroxil.

Source: Alkermes PLC; April 8, 2014.

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