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FDA Accepts Alkermes Application for ALKS 3831

January 29, 2020

The US Food and Drug Administration (FDA) has accepted Alkermes’ New Drug Application (NDA) for ALKS 3831, a novel combination of olanzapine and samidorphan, the company announced. The application seeks approval of the investigational drug for the treatment of both schizophrenia and bipolar disorder.

The NDA has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 15, 2020, according to a statement from Alkermes.

ALKS 3831 Well-Tolerated in Extension Study for Schizophrenia

ALKS 3831 is an oral atypical antipsychotic to be taken once daily. It is designed to provide the efficacy of olanzapine while mitigating the weight gain typically associated with olanzapine.

Alkermes is seeking approval for 10 mg of samidorphan coformulated with 5 mg, 10 mg, 15 mg, or 20 mg of olanzapine in a bilayer tablet.

Reference

Alkermes announces US Food and Drug Administration acceptance of ALKS 3831 New Drug Application for treatment of schizophrenia and bipolar I disorder [press release]. Dublin, Ireland: Alkermes; January 28, 2020.

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