Alkermes' aripiprazole formulation meets schizophrenia endpoints

Alkermes plc (NASDAQ:ALKS) reported Phase III data for an extended-release formulation of aripiprazole lauroxil to treat schizophrenia and said it plans to submit an NDA for the product next quarter. Once-monthly 441 and 882 mg intramuscular aripiprazole lauroxil each met the primary endpoint of improving Positive and Negative Syndrome Scale (PANSS) scores from baseline to week 12 vs. placebo (p<0.001 for both). The double-blind trial enrolled 623 patients experiencing acute exacerbation of schizophrenia. The product is an injectable, extended-release formulation of aripiprazole that uses Alkermes' LinkeRx technology.

Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) and Bristol-Myers Squibb Co. (NYSE:BMY) market a once-monthly aripiprazole formulation in the U.S. and EU as Abilify Maintena. On a conference call to discuss the data, Alkermes said its formulation offers physicians the ability to titrate patients to a higher dose. According to the U.S. and EU labels for Abilify Maintena, the recommended starting and maintenance dose is 400 mg. Alkermes also said its product comes in prefilled syringes and can be administered in the deltoid or gluteal muscles. Abilify Maintena requires reconstitution and can only be administered in the gluteal muscle. ...