Alkermes to submit schizophrenia med this year

Share this article:

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.

Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Business Briefs

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Business Briefs

Novartis said to be stepping out of HCV

Novartis is said to have relinquished rights to an investigational hep. C treatment, signaling its exit from the therapeutic space, according to a former partner's announcement.

Monday Moves: September 15

Hires and promotions for manufacturers, regulatory and agencies

Kantar acquires Evidências, expands Brazilian presence

The company's acquisition signals the growing importance of understanding the Brazilian healthcare market and evidence-based healthcare management services.