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# Alkermes NDA for Major Depressive Disorder Combo Drug
- URL: https://www.fdaweb.com/alkermes-nda-for-major-depressive-disorder-combo-drug/
- Published: 2018-01-31T12:00:00.000Z
- Updated: 2026-09-14T23:18:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140646

Alkermes has filed an NDA for ALKS 5461 (buprenorphine and samidorphan), a once-daily, oral investigational drug for the adjunctive treatment of major depressive disorder (MDD). The submission is based on data from more than 30 clinical trials and more than 1,500 patients with MDD. Buprenorphine is a partial mu-opioid receptor agonist and kappa-opioid receptor antagonist, and samidorphan is a mu-opioid receptor antagonist. Previously, the agency granted the product fast track status for treating MDD **i**n patients with an inadequate response to standard antidepressant therapies.