Posted by Michael Wonder on 20 Nov 2019
Alkermes submits new drug application to U.S. FDA for ALKS 3831 for treatment of schizophrenia and bipolar I disorder
19 November 2019 - Alkermes today announced that it has submitted a new drug application to the U.S. 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 application includes data from the ENLIGHTEN clinical development program in patients with schizophrenia, as well as pharmacokinetic bridging data comparing ALKS 3831 and Zyprexa (olanzapine).
