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Alkermes Submits Dual-Indication NDA for ALKS 3831

November 19, 2019

Alkermes has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for approval of the investigational drug ALKS 3831, a combination of the antipsychotic olanzapine and samidorphan, a novel molecular entity.

The company is seeking indications for the treatment of schizophrenia, maintenance treatment of bipolar I disorder, and the treatment of manic or mixed episodes associated with bipolar I disorder as a monotherapy or adjunct to lithium or valproate.

The once-daily oral atypical antipsychotic is designed to provide the efficacy of olanzapine while mitigating weight gain often associated with it.

Extended Olanzapine Treatment May Lower Risk of Psychotic-Depression Relapse

The NDA includes data from the ENLIGHTEN clinical development program, which featured 2 studies in patients with schizophrenia. ENLIGHTEN-1 evaluated the efficacy of ALKS 3831, compared with placebo over 4 four weeks. ENLIGHTEN-2 assessed weight gain with the combination treatment, compared with olanzapine over 6 months.

The application also includes studies evaluating the pharmacokinetic and metabolic profile and long-term safety of ALKS 3831 and pharmacokinetic bridging studies comparing it with olanzapine (Zyprexa).

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

—Terri Airov


Alkermes submits New Drug Application to US Food and Drug Administration for ALKS 3831 for treatment of schizophrenia and bipolar I disorder [press release]. DUBLIN, Ireland: Alkermes plc; November 19, 2019.

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