Alkermes plc (NASDAQ: ALKS) today announced completion of patient enrollment in the pivotal, multinational phase 3 study evaluating aripiprazole lauroxil in patients with schizophrenia. Aripiprazole lauroxil is designed to provide patients with once-monthly dosing of a medication that, once in the body, converts into aripiprazole, a molecule that is commercially available under the name ABILIFY®. Alkermes continues to expect topline results from the phase 3 study in the first half of 2014.
Enrollment was completed following a prespecified interim analysis of sample size. This analysis, designed to preserve the integrity of the final efficacy analysis and performed by an independent statistical center, indicated that a sample size of 540 patients or more would have sufficient statistical power to evaluate the primary endpoint. The study continues to be blinded until completion.
"There is a clear and compelling need for long-acting injectable medicines for patients with schizophrenia," said Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. "We are excited to complete enrollment in this carefully conducted, multinational study and look forward to reporting the results in the first half of 2014."
The phase 3 pivotal clinical trial of aripiprazole lauroxil is a 12-week, 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 primary endpoint is the change from baseline in Positive and Negative Syndrome Scale (PANSS) total score, which is a standard outcome measure in the evaluation of schizophrenia treatment. The clinical data from this study will form the basis of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for aripiprazole lauroxil for the treatment of schizophrenia.