Aripiprazole lauroxil success in Phase III trial for monthly treatment of Schizophrenia - Alkermes

Alkermes plc announced positive topline results from a randomized, double-blind, placebo-controlled phase III clinical trial of aripiprazole lauroxil 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 to placebo which was the prespecified primary endpoint in the study. Based on the positive results from this phase III study, Alkermes plans to submit a New Drug Application (NDA) 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 name Abilify.