Alkermes announced positive results from its Phase 3 clinical trial of aripiprazole lauroxil in patients with schizophrenia. Aripiprazole lauroxil, which utilizes Alkermes’ proprietary LinkeRx technology, is an injectable long-acting atypical antipsychotic with one-month and two-month formulations in development. Once in the body, aripiprazole lauroxil converts to aripiprazole, which is commercially available as Abilify (BMS/Otsuka).

The study was a multicenter, double-blind, placebo-controlled study designed to assess the efficacy, safety and tolerability of aripiprazole lauroxil in patients experiencing acute exacerbation of schizophrenia. The trial randomized 623 adult patients who met the DSM-IV-TR criteria for schizophrenia and had a Positive and Negative Syndrome Scale (PANSS) total score of 70 or higher at study baseline to receive once-monthly intramuscular injections of aripiprazole lauroxil 441mg, aripiprazole lauroxil 882mg, or placebo for 12 weeks. The primary efficacy endpoint of the study was the change from baseline and week 12 in PANSS total score.

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All participants in the double-blind portion of the study are 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.

Statistically significant reductions were observed from baseline in PANSS total scores compared to week 12 in patients treated with either 441mg or 882mg of aripiprazole lauroxil once monthly vs. placebo (P<0.001 aripiprazole lauroxil 441mg, P<0.001 aripiprazole lauroxil 882mg).

Based on the positive results from this Phase 3 study, Alkermes plans to submit a New Drug Application (NDA) to the FDA in the third quarter of 2014.

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