Alkermes Expands Planned New Drug Application For ALKS 3831 To Include Treatment Of Bipolar I Disorder

Alkermes provided an update on its regulatory strategy for ALKS 3831 (olanzapine/samidorphan), the company's novel, once-daily, oral atypical antipsychotic drug candidate designed to provide the efficacy of olanzapine, while mitigating olanzapine-associated weight gain. Following a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA), the company plans to expand the NDA for ALKS 3831 to encompass the treatment of bipolar I disorder, in addition to the treatment of schizophrenia. 

The ALKS 3831 NDA, which the company now plans to submit in the fourth quarter of 2019, will include data from . . .