Two advisory committees appointed by the US Food and Drug Administration (FDA) have voted in favor of ALKS 3831, a combination of olanzapine and samidorphan, with a majority agreeing that samidorphan meaningfully mitigates weight gain associated with olanzapine and that its safety profile has been adequately characterized, Alkermes announced.
The votes came during a joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The recommendations are not binding, but will be considered by the FDA during in its review of the New Drug Application for ALKS 3831, which has a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 15, 2020.
ALKS 3831 is a novel, once-daily, oral atypical antipsychotic proposed for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder. It combines samidorphan, a new molecular entity, with olanzapine in a bilayer tablet.
"The favorable outcome of today's joint advisory committee meeting represents an important milestone for the patients, clinicians and families who may benefit from new medicines for the treatment of schizophrenia and bipolar I disorder," said Craig Hopkinson, MD, chief medical officer and executive vice president of research and development at Alkermes.
The committees voted 16-1 that samidorphan meaningfully mitigates olanzapine-associated weight gain, and 13-3, with 1 abstention, that the safety profile of ALKS 3831 has been adequately characterized, according to a press release from Alkermes. They also voted 11-6 that the drug’s labeling sufficiently mitigates risks related to the opioid antagonist action of samidorphan, according to the release.
“Alkermes' proposed labeling contraindicates the use of ALKS 3831 in patients who are opioid-dependent or chronically using opioids, and the company has proposed a comprehensive education plan, which includes dissemination of information to potential prescribers and pharmacists,” the company said in its statement.
ALKS 3831 has been evaluated in 18 studies and 9 studies have evaluated samidorphan alone, according to Alkermes.