Advancing PTSD Treatment: What's Taken So Long?

Rebecca Barbee, PA-C, CAQ-Psych, had one thought about the upcoming US Food and Drug Administration Meeting of the Psychopharmacologic Drugs Advisory Committee to discuss the supplemental New Drug Application for brexpiprazole (Rexulti) for the treatment of posttraumatic stress disorder (PTSD) in adults in combination with sertraline:¹ What's taken so long?

Barbee, a physician associate at Southlake Psychiatry in Davidson, North Carolina, noted brexpiprazole is unique and makes a good candidate for addressing PTSD because it has high binding affinity to norepinephrine, in addition to serotonin and dopamine. "It makes sense why this would be looked at as far as PTSD," Barbee said in an exclusive interview with Psychiatric Times. "I think a lot of clinicians have already been using it on label for a major depressive disorder, but maybe someone also happens to have PTSD."

"There aren't a lot of options as far as medication," Barbee said in terms of treating PTSD and the need for agents like brexpiprazole. "This is very validating that the industry and clinicians are hearing them [patients] and looking for additional solutions to help them."

Barbee said it is essential to routinely assesses for trauma history in patients. "Every new patient, I do screen for a history of trauma, but then I also screen again a few months later, once I've gotten to know them, because it can be really, really hard to talk about a lot of things that we talk about in an initial evaluation," she told Psychiatric Times.

Although the FDA Advisory Committee meeting is not an approval process, it does play a role and signals a potential step closer for approval. On their website, the FDA states that the committee provides:¹

Independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so.

It has been 20 years since the last new agent was approved for treating PTSD, so all eyes on the meeting, which is scheduled for Friday, July 18, 2025.² The meeting is open to the public.

"I'm very excited and very hopeful," Barbee shared.

Full coverage of the meeting including expert perspectives of the decision and what it means for clinicians and their patients will be available at PsychiatricTimes.com.

References

1. FDA. July 18, 2025: Meeting of the Psychopharmacologic Drugs Advisory Committee Meeting Announcement. Press release. Accessed July 16, 2025. https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-18-2025-meeting-psychopharmacologic-drugs-advisory-committee-meeting-announcement-07182025#event-information

2. Kuntz L. Rexulti in Combination With Sertraline for PTSD: Upcoming FDA Advisory Committee Discussion. Psychiatric Times. July 16, 2025. Accessed July 16, 2025. https://www.psychiatrictimes.com/view/rexulti-in-combination-with-sertraline-for-ptsd-upcoming-fda-advisory-committee-discussion