Alkermes Submits New Drug Application To FDA For ALKS 3831 For Treatment Of Schizophrenia And Bipolar I Disorder

Alkermes plc (NASDAQ:ALKS) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of ALKS 3831 (olanzapine/samidorphan) for the treatment of

Benzinga · 11/19/2019 12:00

Alkermes plc (NASDAQ:ALKS) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and for the treatment of 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 olanzapine-associated weight gain. The ALKS 3831 NDA includes data from the ENLIGHTEN clinical development program in patients with schizophrenia, as well as pharmacokinetic (PK) bridging data comparing ALKS 3831 and ZYPREXA® (olanzapine).