FDA Advisory Committee Rejects Lundbeck and Otsuka’s PTSD Bid for Rexulti

The FDA's Psychopharmacologic Drugs Advisory Committee (PDAC) reviewed the supplemental New Drug Application (sNDA) for Rexulti (brexpiprazole) in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD)13.

The committee voted 1-10 against the proposal, concluding that the efficacy of brexpiprazole, when started concurrently with sertraline, has not been established for PTSD based on the available data13.

FDA reviewers expressed concern over 'discordant results' from clinical trials, with one phase 3 trial failing to show efficacy over sertraline (Zoloft) monotherapy, complicating the evidence for the drug's effectiveness24.

Despite this setback, Otsuka and Lundbeck stated they remain committed to working with the FDA during the ongoing review process and believe in the treatment's potential for PTSD patients13.

Sources:

1. https://news.cision.com/h--lundbeck-a-s/r/otsuka-and-lundbeck-issue-statement-on-u-s--food-and-drug-administration--fda--advisory-committee-me,c4208413

2. https://www.fiercepharma.com/pharma/lundbeck-and-otsuka-ptsd-filing-fda-questions-rexulti-efficacy-after-failed-ph-3

3. https://www.lundbeck.com/us/newsroom/2025/otsuka-and-lundbeck-issue-statement-on-u-s--food-and-drug-admini

4. https://www.psychiatrictimes.com/view/rexulti-for-ptsd-discordant-results-flagged-by-fda-reviewers