FDA Rejects Lundbeck and Otsuka’s Rexulti for PTSD on Insufficient Efficacy Evidence

The U.S. FDA has rejected the supplemental New Drug Application (sNDA) for Rexulti (brexpiprazole) in combination with sertraline for treating adults with post-traumatic stress disorder (PTSD) due to lack of substantial evidence of effectiveness135.

Otsuka and Lundbeck submitted data from three randomized clinical trials evaluating the safety and efficacy of the combination therapy; however, not all studies were deemed capable of providing substantial evidence, and overall efficacy was not established135.

The FDA's Psychopharmacologic Drugs Advisory Committee voted 1–10 against the approval in July 2025, citing insufficient evidence for efficacy in the submitted studies1245.

The Complete Response Letter from the FDA stated that additional positive, adequate, and well-controlled trials would be required to support future approval135.

Otsuka and Lundbeck have indicated they will review the FDA's feedback to determine their next steps, but reiterated their belief in the potential of Rexulti for PTSD135.

Sources:

1. https://www.pharmatutor.org/pharma-news/2025/fda-rejects-otsuka-and-lundbecks-bid-for-rexulti-in-ptsd-treatment

2. https://www.biospace.com/fda/otsuka-lundbeck-fail-to-sway-adcomm-on-rexulti-combo-for-ptsd

3. https://www.otsuka.co.jp/en/company/newsreleases/2025/20250920_1.html

4. https://www.empr.com/news/fda-panel-votes-against-brexpiprazole-plus-sertraline-for-ptsd/

5. https://chemxpert.com/all-news/fda-rejects-otsuka-lundbecks-ptsd-snda-for-rexulti-sertraline