FDA to Convene Advisory Committee on Brexpiprazole-Sertraline for Adult PTSD

The US Food and Drug Administration (FDA) plans to hold a Psychopharmacologic Drugs Advisory Committee (PDAC) meeting to discuss the Supplemental New Drug Application (sNDA) for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD), according to a news release from H. Lundbeck A/S, which is co-developing the therapy with Otsuka.¹

The meeting date has not yet been determined but is anticipated to occur in the first half of 2025. This decision means the agency expects to miss the Prescription Drug User Fee Act (PDUFA) target action date of February 8, 2025.

The FDA’s decision to convene an advisory committee does not indicate a final determination on approval status.

According to Phase 3 trial results published in JAMA Psychiatry in December 2024, brexpiprazole combined with sertraline produced significantly greater reductions in PTSD symptoms than sertraline plus placebo.² Among 416 participants, those receiving the dual therapy achieved clinically meaningful improvements in their Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total scores after 10 weeks. The study authors said these findings offer hope for a new therapeutic option, noting that only about half of individuals with PTSD seek treatment despite an estimated 6% lifetime prevalence in the United States.²

References

1. Lundbeck announces FDA plans to host an Advisory Committee meeting on the sNDA for brexpiprazole in combination with sertraline for the treatment of adults with PTSD [news release]. January 9, 2025. Accessed January 9, 2025. https://news.cision.com/h--lundbeck-a-s/r/lundbeck-announces-fda-plans-to-host-an-advisory-committee-meeting-on-the-snda-for-brexpiprazole-in-,c4089526
2. Jennings S. Brexpiprazole and sertraline combination therapy shows efficacy in treating PTSD. Patient Care Online. December 18, 2025. https://www.patientcareonline.com/view/brexpiprazole-and-sertraline-combination-therapy-shows-efficacy-in-treating-ptsd