FDA panel says no to Alkermes depression pill

Nov 02, 2018

An advisory panel to the U.S. FDA voted against approving Alkermes’ treatment for depression in patients with an inadequate response to standard antidepressant therapies.

The panel voted 21-2 against the drug, ALKS 5461, a once-daily pill combining samidorphan and buprenorphine, developed as an add-on treatment for major depressive disorder.

FDA staff reviewers flagged abuse potential for the opioid-based treatment and raised questions on its efficacy.

Read the press release

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