FDA to Review Aripiprazole Lauroxil NDA for Schizophrenia
Alkermes announced that the Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for aripiprazole lauroxil, a once-monthly injectable atypical antipsychotic for the treatment of schizophrenia.
The NDA filing included positive results from the randomized, multicenter, double-blind, placebo-controlled Phase 3 study assessing the efficacy and safety of aripiprazole lauroxil. In the study, aripiprazole lauroxil demonstrated significant improvements in schizophrenia symptoms, compared to placebo. Both doses of aripiprazole lauroxil tested in this trial, 441mg and 882mg once monthly, met the primary endpoint with statistically significant and clinically meaningful reductions in Positive and Negative Syndrome Scale (PANSS) scores.
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