FDA approves longer-acting schizophrenia drug

The US Food and Drug Administration today granted approval of Ireland-incorporated Alkermes’ (Nasdaq: ALKS) two-month Aristada (aripiprazole lauroxil), a long-acting antipsychotic treatment for schizophrenia.

The new two-month dose is expected to be available in mid-June. The 1064 mg dose becomes the only 2 month antipsychotic on the market. News of the approval sent Alkermes’ share as high as $59.55, and they were still up 1.5% at $58.91 by late-morning trading.

The approval of Aristada two-month dosing option allows greater flexibility for patients and healthcare professionals to manage a disease where the challenges of treatment adherence are well-documented. Non-adherence to medication is a recognized problem across the industry and may be the most challenging aspect of treatment - as is evident by the more than one third of patients with schizophrenia per year impacted by non-adherence.