Alkermes presents aripiprazole lauroxil phase 3 data Alkermes announced the presentation of data from its phase 3 clinical trial of aripiprazole lauroxil at the American Society of Clinical Psychopharmacology Annual Meeting. In the pivotal study, both doses of aripiprazole lauroxil tested, 441 mg and 882 mg administered once-monthly, met the primary endpoint with statistically and clinically significant reductions in Positive and Negative Syndrome Scale scores, met all secondary endpoints and demonstrated significant improvements in schizophrenia symptoms versus placebo. This is the first demonstration of the efficacy of a range of doses of a long-acting injectable form of aripiprazole in a randomized clinical trial. The company remains on track to submit a New Drug Application to the U.S. Food and Drug Administration in 3Q14. Aripiprazole lauroxil was generally well tolerated in the study, and the observed safety profile of aripiprazole lauroxil was similar to that reported with oral aripiprazole. The most common adverse events in the study were insomnia, akathisia and headache.
JPMorgan to hold a conference 33rd Annual Healthcare Conference is being held in San Francisco on January 12-15 with webcasted company presentations to begin on January 13 at 10:30 am; not all company presentations may be webcasted. Webcast Link