Irish biopharmaceutical company Alkermes plc (ALKS) announced Monday that it has submitted a New Drug Application or NDA to the U.S. Food and Drug Administration or FDA for approval of aripiprazole lauroxil.
The company noted that aripiprazole lauroxil is its investigational, novel, once-monthly, long-acting injectable atypical antipsychotic for the treatment of schizophrenia, a chronic, severe and disabling brain disorder.
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 to placebo.
According to the firm, the drug has the potential to be novel once-monthly product for schizophrenia with differentiated profile, including ready-to-use format and multiple dose strengths.
The NDA submission follows the completion of the randomized, multicenter, double-blind, placebo-controlled, phase 3 study, in which both doses of aripiprazole lauroxil tested, 441 mg and 882 mg administered once monthly, met the primary endpoint.
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.
Richard Pops, Chief Executive Officer of Alkermes, said, "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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