Alkermes submits NDA for aripiprazole

Alkermes plc (NASDAQ:ALKS) submitted an NDA to FDA for aripiprazole lauroxil ( ALKS 9070, ALKS 9072) to treat schizophrenia. The product is a once-monthly, injectable formulation of aripiprazole, an atypical antipsychotic that uses Alkermes' LinkeRx technology.

If approved, the dopamine D2 receptor and serotonin (5-HT) receptor agonist would compete with Abilify Maintena, a once-monthly formulation of aripiprazole from Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) and Bristol-Myers Squibb Co. (NYSE:BMY). Unlike Abilify Maintena, which needs to be reconstituted, Alkermes' version would come in prefilled syringes and would allow physicians to titrate patients to a higher dose. ...