FDA Advisory Board In Favor of ALKS 3831 for Schizophrenia & Bipolar Disorder

October 9, 2020

The schizophrenia drug currently has a PDUFA date set for November 15.

A US Food and Drug Administration’s (FDA) advisory committee has given a recommendation for the ultimate approval of a combination of olanzapine and samidorphan (ALKS 3831) in schizophrenia patients.

During the joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, the group voted 16-1 that the samidorphan meaningfully mitigates olanzapine-associated weight gain with a 16-1 vote.

The committee also ruled the safety profile of ALKS 3831, developed by Alkermes, has been adequately characterized with a 13-3 vote.

Finally, the committees jointly voted that labeling is sufficient to mitigate the risks related to the opioid antagonist action of samidorphan in a 11=6 vote.

ALKS 3831 is an investigational, novel atypical antipsychotic earmarked for once-daily oral application for the 2 psychiatric disorders composed of samidorphan, a novel, new molecular entity, co-formulated with olanzapine, an established antipsychotic agent in a single bilayer tablet.

Recently, researchers presented data from the ENLIGHTEN-2 trial, a six-month study evaluating the weight gain profile of ALKS 3831 compared to olanzapine in 561 patients with stable schizophrenia.

“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,” Craig Hopkinson, MD, chief medical officer and executive vice president of R&D at Alkermes, said in a statement. The personal testimonies shared during today’s open public hearing reinforced the need for treatment approaches that consider patients’ overall mental and physical health. The ALKS 3831 development program is part of our ongoing commitment to develop new therapeutic options for adults living with serious mental illness.”

There is currently a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 15.