On Friday July 18, 2025, the US Meals and Drug Administration (FDA) advisory committee will focus on the supplemental New Drug Software (sNDA) for brexpiprazole (Rexulti) tablets, submitted by Otsuka Pharmaceutical Firm, for the therapy of adults with posttraumatic stress dysfunction (PTSD), together with sertraline.1
With no new therapies for PTSD in practically 25 years and roughly 13 million Individuals fighting the dysfunction,2 this information gives a beacon of hope after the disappointing consequence for midomafetamine (MDMA)-assisted psychotherapy (MDMA-AT) late final 12 months.3
In August 2024, the FDA issued an entire response letter for MDMA-AT for PTSD, requesting an extra section 3 trial to look at security and efficacy, relatively than the approving the psychedelic.4 Many have been saddened by this outcome, together with federal veterans advocates on the Heroic Hearts Venture. “The FDA’s resolution is a missed alternative to embrace groundbreaking science, save numerous Veteran lives, and honor the sacrifices made by those that served our nation. If this crucial therapy stays inaccessible, we face shedding an extra 6000 Veterans to suicide this 12 months alone—and yearly thereafter,” shared Heroic Hearts in an announcement following the denial of MDMA-AT.5 The push for MDMA-AT’s approval additionally had bipartisan assist; Over 60 members of Congress from each events despatched a letter to President Biden, his administration, and FDA officers, urging them to “observe the science” when it got here to MDMA-AT.6
Rexulti, whereas new to the PTSD house, is already available on the market for a number of different illness states. It was authorised by the FDA in 2015 as an adjunctive remedy to antidepressants in adults with main depressive dysfunction (MDD) and as a monotherapy therapy for schizophrenia in adults, and was most not too long ago authorised in Might 2023 for the therapy of agitation related to Alzheimer illness dementia—the primary FDA-approved therapy possibility for this indication.7 Though the mechanism of motion of Rexulti is unknown, it has excessive receptor binding affinity to norepinephrine, serotonin, and dopamine receptors, and is an antagonist at norepinephrine α1B and α2C receptors and serotonin 5-HT2A receptors, in addition to a partial agonist at serotonin 5-HT1A and dopamine D2 receptors.
The unique Prescription Drug Consumer Price Act goal motion date for Rexulti together with sertraline for PTSD was deliberate for February 8, 2025, and has been postponed till after this week’s advisory committee dialogue.
Keep tuned for extra protection on the end result of the advisory committee assembly, proper right here at PsychiatricTimes.com.
References
1. July 18, 2025: Assembly of the Psychopharmacologic Medication Advisory Committee Assembly Announcement. US Meals and Drug Administration. Accessed July 15, 2025. https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-18-2025-meeting-psychopharmacologic-drugs-advisory-committee-meeting-announcement-07182025
2. How widespread is PTSD in adults? US Division of Veterans Affairs. Up to date March 26, 2025. Accessed July 15, 2025. https://www.ptsd.va.gov/perceive/widespread/common_adults.asp
3. Duerr HA. With MDMA on maintain, what’s subsequent for psychedelics? Psychiatric Instances. September 11, 2024. https://www.psychiatrictimes.com/view/with-mdma-on-hold-whats-next-for-psychedelics
4. Lykos Therapeutics publicizes full response letter for midomafetamine capsules for PTSD. August 9, 2024. Accessed July 15, 2025. https://information.lykospbc.com/2024-08-09-Lykos-Therapeutics-Declares-Full-Response-Letter-for-Midomafetamine-Capsules-for-PTSD
5. Heroic Hearts and Therapeutic Breakthrough response to FDA’s Denial of MDMA-AT. Heroic Hearts Venture. August 9, 2024. Accessed July 15, 2025. https://heroicheartsproject.org/response-to-fdas-denial-of-mdma-at/
6. Bergman leads 60 members in letter to spotlight new groundbreaking remedy, cease veteran suicide. Information launch. August 5, 2024. Accessed. July 15, 2025. https://bergman.home.gov/information/documentsingle.aspx?DocumentID=1303
7. Kuntz L. FDA approves first therapy for agitation related to Alzheimer illness dementia. Psychiatric Instances. Might 10, 2023. https://www.psychiatrictimes.com/view/fda-approves-first-treatment-for-agitation-associated-with-alzheimer-disease-dementia
