Alkermes submits NDA to FDA for aripiprazole lauroxil for treatment of schizophrenia

Potential to be novel once-monthly product for schizophrenia with differentiated profile, including ready-to-use format and multiple dose strengths

Alkermes has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for approval of aripiprazole lauroxil, the company’s investigational, novel, once-monthly, long-acting injectable atypical antipsychotic for the treatment of schizophrenia. The data submitted as part of this NDA include the positive results from the pivotal phase 3 study assessing the efficacy and safety of aripiprazole lauroxil, in which aripiprazole lauroxil demonstrated significant improvements in schizophrenia symptoms, compared with placebo.

The NDA submission follows the completion of the randomised, multicentre, double-blind, placebo-controlled phase 3 study, in which both doses of aripiprazole lauroxil tested, 441mg and 882mg administered once monthly, met the primary endpoint with statistically significant and clinically meaningful reductions in Positive and Negative Syndrome Scale (PANSS) scores, met all secondary endpoints and demonstrated significant improvements in schizophrenia symptoms versus placebo. Aripiprazole lauroxil was generally well tolerated in the study, and the observed safety profile of aripiprazole lauroxil was similar to that reported with oral aripiprazole. The most common adverse events in the study were insomnia, akathisia and headache.

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. As a long-acting investigational medication based on Alkermes’ proprietary LinkeRx technology, aripiprazole lauroxil is designed to have multiple dosing options and to be administered in a ready-to-use, pre-filled product format.

'We have designed aripiprazole lauroxil to be a differentiated treatment option for schizophrenia, with a ready-to-use format with multiple dosing options, to help meet the individual needs of patients and their healthcare providers,' said Richard Pops, Chief Executive Officer of Alkermes. 'These attributes, together with the robust clinical data observed in the pivotal study, position aripiprazole lauroxil to be a meaningful new entrant in the growing long-acting injectable antipsychotic market, and we look forward to working with the FDA to bring this important new medication to patients and physicians as quickly as possible.'

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