Aripiprazole Lauroxil NDA Submitted for Schizophrenia

Alkermes announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for aripiprazole lauroxil for the treatment of schizophrenia. Aripiprazole lauroxil is an investigational once-monthly, long-acting injectable atypical antipsychotic.

The NDA submission was based on positive results from its pivotal Phase 3 randomized, multicenter, double-blind, placebo-controlled study designed to assess the efficacy and safety of aripiprazole lauroxil. In the study aripiprazole lauroxil demonstrated significant improvements in schizophrenia symptoms compared to placebo. The primary endpoint was met with statistically significant and clinically meaningful reductions in Positive and Negative Syndrome Scale (PANSS) scores.

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