Alkermes files for US approval of ALKS 3831

19 November 2019

Ireland-incorporated biotech Alkermes (Nasdaq: ALKS) has filed a New Drug Application (NDA) to the US Food and Drug Administration 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).

"Antipsychotic medications are an important part of the treatment paradigm for both schizophrenia and bipolar I disorder, yet there remains a persistent unmet need for new treatments," said Dr Craig Hopkinson, chief medical officer and senior vice president of medicines development and medical affairs at Alkermes.

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