Dublin’s Alkermes plc is gearing up to file its experimental schizophrenia medication with the FDA by the third quarter of this year. The company said in a statement Tuesday that Phase-III results, which demonstrated the impact of the monthly injection, are behind its submission plans.
Three patient cohorts were studied: one which received 441 mg of aripiprazole lauroxil, another given 882 mg of the same drug, and a third that served as the control group. The extended-release drug converts the medication into aripiprazole, also known as Abilify.
Data showed “statistically significant reductions from baseline in Positive and Negative Syndrome Scale,” at 12 weeks.
Tuesday’s news follows last month’s J&J announcement that it, too, was going to file a long-acting schizophrenia medication with the FDA. J&J said it expects to submit its request for the drug, intended to be dosed four times a year, by the end of 2014.
