Alkermes to submit schizophrenia med this year

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.

You must be a registered member of MMM to post a comment.
close

Next Article in Channel

 

Did you miss January's Top 40 Healthcare Transformers issue? Read how these inventors, strategists, entrepreneurs and wonks are challenging, disrupting and otherwise transforming the healthcare business. And join us April 30 to honor them at the Transforming Healthcare Dinner. Click here.