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# FDA Rejects sNDA for Rexulti’s Use in PTSD
- URL: https://www.fdaweb.com/fda-rejects-snda-for-rexultis-use-in-ptsd/
- Published: 2025-09-22T12:00:00.000Z
- Updated: 2026-09-14T15:22:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159909

FDA has rejected Otsuka Pharmaceutical and H. Lundbeck’s bid to expand the use of Rexulti (brexpiprazole) for treating post-traumatic stress disorder in adults. An agency-issued complete response letter said the application, which sought approval for Rexulti in combination with the antidepressant sertraline (Zoloft), did not provide “substantial evidence of effectiveness” to support approval, according to the companies.

The decision follows a 7/18 meeting of the Psychopharmacologic Drugs Advisory Committee, where panelists voted 10-1 against approving the combination treatment based on the efficacy data submitted. An agency [briefing document](https://www.fda.gov/media/187617/download?ref=fdaweb.com) released before the meeting saw medical reviewers citing inconsistent trial results and a modest treatment effect that they wrote may not be clinically meaningful as reasons for raising efficacy concerns.

Rexulti is currently approved by FDA for treating agitation in patients with Alzheimer’s disease and for adults with major depressive disorder and schizophrenia.