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Pharmaceuticals / Regulatory Affairs

FDA Expert Panel Gives Mixed Reviews of Opioid Treatment for Depression

Nov. 9, 2018

An FDA advisory panel voted against the effectiveness and benefit-risk profile of Alkermes’ NDA for buprenorphine/samidorphan to treat major depressive disorder but in favor of its safety.

Members of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 20-3 against the NDA’s efficacy.

Kathryn E. Flynn, an associate professor of medicine at the Center for International Blood & Marrow Transplant Research in Milwaukee, said she based her “no” vote on the sponsor’s “lack of substantial evidence,” while Marie R. Griffin, a professor of health policy and medicine at Vanderbilt University Medical Center, criticized the sponsors for use of an ineligible pilot study among its trial data.

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