Alkermes Submits New Drug Application To FDA For Treatment Of Schizophrenia & Bipolar I Disorder

Alkermes announced that it has submitted a new drug application to the U.S. Food and Drug Administration seeking approval of ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and bipolar I disorder. ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate designed to provide the efficacy of olanzapine while mitigating weight gain associated with olanzapine. The ALKS 3831 NDA includes data from the ENLIGHTEN clinical development program in individuals with schizophrenia, as well as pharmacokinetic bridging data comparing ALKS 3831 and ZYPREXA® (olanzapine).

The ALKS 3831 NDA includes data to support an indication for . . .