Alkermes files NDA for aripiprazole lauroxil in schizophrenia

Ireland-headquartered biotech firm Alkermes (Nasdaq: ALKS) has submitted a New Drug Application to the US Food and Drug Administration for approval of aripiprazole lauroxil, the company’s investigational, novel, once-monthly, long-acting injectable atypical antipsychotic for the treatment of schizophrenia. The news pushed Alkermes’ shares up 2.3% to $44.22 in New York trading yesterday.

The data submitted as part of this NDA include the positive results from the pivotal Phase III study assessing the efficacy and safety of aripiprazole lauroxil, in which aripiprazole lauroxil demonstrated significant improvements in schizophrenia symptoms, compared to placebo.

Aripiprazole lauroxil is an injectable atypical antipsychotic with one-month and two-month formulations in development for the treatment of schizophrenia. Once in the body, aripiprazole lauroxil converts to aripiprazole, which is commercially available under the name Abilify from Japan’s Otsuka, the USA’s Bristol-Myers Squibb and Denmark’s Lundbeck and generated $6.5 billion in US sales last year.