FDA Advisory Committee Votes in Favor of ALKS 3831

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Alkermes plc announced Friday, October 9, that the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted favorably for ALKS 3831 (olanzapine/samidorphan). ALKS 3831 is an investigational, oral antipsychotic drug candidate for the treatment of adults with schizophrenia or bipolar I disorder. The committees voted ALKS 3831 significantly diminishes olanzapine-associated weight gain (16 yes, 1 no) and that the safety profile of ALKS 3831 was correctly characterized (13 yes, 3 no, 1 abstention).

“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,” said Craig Hopkinson, MD, Chief Medical Officers and Executive Vice President of Research & Development at Alkermes, in a release to press.¹ He added, “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 committees’ decisions will be taken into consideration by the FDA when completing the review of ALKS 3831 New Drug Application (NDA).

The NDA submission and clinical development program for ALKS 3831 are supported by data from 27 clinical studies. Of these 27 studies, 18 evaluated ALKS 3831, and 9 studies evaluated samidorphan alone.

Additionally, the committees voted that labeling is sufficient to mitigate the risks related to the opioid antagonist action of samidorphan (11 yes, 6 no); among the important queries posed for the FDA was the effects and outcomes of ALKS 3831 for patients who used opioids. Notes from reviewers included that ALKS 3831 could lead to withdrawal in patients who are opioid-dependent, could block the opioid pain-relief effects, or even lead to overdose if someone tried to overcome the effects of the antagonist.

Alkermes’ proposed solution to this problem is including a note indicated that it is contraindicated for those patients taking opioids. The FDA has not yet indicated whether this solution has resolved their concerns.

An FDA decision on this drug is due November 15, 2020.

 Reference

1. FDA Advisory Committee Votes in Support of ALKS 3831 for the Treatment of Schizophrenia and Bipolar I Disorder. News release. Alkermes. October 9, 2020. Accessed October 12, 2020. https://investor.alkermes.com/news-releases/news-release-details/fda-advisory-committee-votes-support-alks-3831-treatment​