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.
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.
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.