The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ALKS 3831 (Alkermes) for the treatment of schizophrenia and bipolar I disorder. 

ALKS 3831 is composed of a novel molecular entity, samidorphan, a mu-opioid receptor antagonist, which is co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet. The investigational, once-daily oral formulation is designed to provide the efficacy of olanzapine while mitigating olanzapine-associated weight gain. 

The NDA is supported by data from the Enlighten clinical program, which includes two phase 3 studies. A total of 964 individuals diagnosed with schizophrenia participated. The Enlighten-1 study found that treatment with olanzapine/samidorphan resulted in significant reductions from baseline in Positive and Negative Syndrome Scale (PANSS) scores compared with placebo. The Enlighten-2 study found that olanzapine/samidorphan demonstrated both a lower mean percent weight gain from baseline at 6 months and a lower proportion of patients who gained 10% or more of their baseline body weight at 6 months compared with olanzapine alone (P =.003).

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Alkermes is seeking approval of 4 fixed-dose strengths of olanzapine/samidorphan: 5mg/10mg, 10mg/10mg, 15mg/10mg and 20mg/10mg. A Prescription Drug User Fee Act (PDUFA) target action date of November 15, 2020 has been assigned to the application.

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