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# Alkermes Complete Response Letter on Depression NDA
- URL: https://www.fdaweb.com/alkermes-complete-response-letter-on-depression-nda/
- Published: 2019-02-04T12:00:00.000Z
- Updated: 2026-09-15T01:00:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143293

FDA has issued Alkermes a complete response letter on its NDA for ALKS 5461 for the adjunctive treatment of major depressive disorder. The agency letter requests additional clinical data to provide substantial evidence of the therapy’s effectiveness, according to the company. Alkermes says it plans to meet with FDA soon. 

The NDA submission was based on results from a clinical efficacy and safety package with data from more than 30 clinical trials and more than 1,500 patients with major depressive disorder (MDD). “Throughout the clinical development program, ALKS 5461 demonstrated a consistent profile of antidepressant activity, safety and tolerability in the adjunctive treatment of MDD,” the company says.