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The joint committee’s recommendations will be considered by the FDA in the drug candidate’s new drug application.
The Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee have voted in support of samidorphan and olanzapine (ALKS 3831; Alkermes plc) for the treatment of adults with schizophrenia and adults with bipolar I disorder.
The committees, appointed by the FDA, voted 16 to 1 that samidorphan meaningfully mitigates olanzapine-associated weight gain; the members also voted 13 to 3, with 1 abstaining, that the drug formulation’s safety profile has been adequately characterized. Members additionally voted that labeling is sufficient to mitigate risks associated with samidorphan, with 11 members voting in favor, and 6 voting against the action.
The formulation is an investigational, novel, once-daily oral atypical antipsychotic drug candidate with the prospective ability to treat adults with schizophrenia and to treat adults with bipolar I disorder. The candidate takes the form of a single bilayer tablet comprised of samidorphan – a novel, new molecular entity – and olanzapine – an established antipsychotic agent.
The recommendations put forth by the joint advisory committee will now be considered by the FDA for the candidate’s New Drug Application (NDA), with November 15, 2020 as the Prescription Drug User Fee Act’s (PDUFA) targeted action date.
The formulation’s NDA submission and corresponding clinical development program are based on data from 27 clinical studies, 18 of which evaluated the samidorphan-olanzapine combination, and 9 that evaluated the novel samidorphan alone.
Because samidorphan may produce risks related to its opioid antagonist action, Alkermes has proposed a comprehensive education plan that offers information to potential prescribers and pharmacists.
"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. The personal testimonies shared during today's open public hearing reinforced the need for treatment approaches that consider patients' overall mental and physical health," said Craig Hopkinson, MD, chief medical officer and executive vice president of research and development at Alkermes.
"The ALKS 3831 development program is part of our ongoing commitment to develop new therapeutic options for adults living with serious mental illness. Today's outcome marks an important step for this program and we look forward to working with the FDA as it completes its review of the ALKS 3831 New Drug Application," Hopkinson said.