FDA Advisory Committee Meeting to Review MDMA-Assisted Therapy for PTSD

The US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) will be convening to review data supporting the new drug application (NDA) submitted by Lykos Therapeutics for MDMA-assisted therapy in the treatment of adults with PTSD.¹

The advisory committee meeting, scheduled for June 4, will be the first to consider both an MDMA-assisted therapy and psychedelic-assisted therapy for regulatory approval in the US, according to Lykos.² It is also the first FDA advisory committee meeting to review a potential new PTSD treatment in the last quarter-century.

"We look forward to the opportunity to discuss the comprehensive data package of investigational MDMA and how, if approved, it may be used as a prescription treatment in combination with psychological intervention in adults with PTSD,” Amy Emerson, chief executive officer of Lykos, said in a statement.

Key on the PDAC meeting agenda will be the third-party panel’s review of from Lykos’ pivotal phase 3, randomized, double-blind, placebo-controlled MAPP1 and MAPP2 trials that which assessed the efficacy and safety of MDMA plus psychological intervention versus lone intervention in the treatment of moderate to severe PTSD.³

MAPP1 included participants with severe PTSD, while MAPP2 assessed participants with moderate PTSD. Both trials met the primary endpoint of significant improvement in reduced PTSD symptoms versus lone psychotherapy based on the Clinician-Administered PTSD Scale for DSM-5. The secondary endpoint, improvement in functional impairment associated with PTSD measured by the change from baseline in the Sheehan Disability Scale, was also met in in both trials.

On the weight of the pivotal trials, as well as other clinical research, Lykos submitted their NDA for MDMA-assisted therapy in the treatment of adults with PTSD in late 2023; the application was accepted in February with Priority Review, with a PDUFA target date of August 11, 2024.

“I’m cautiously optimistic that it could be a true game changer,” MAPP lead investigator Jennifer Mitchell, PhD, from the University of California, told HCPLive, in December. “We do not have great therapies right now for PTSD.”⁴

References

1. ^{FDA, Federal Register. Accessed April 2024. Federal Register, Volume 64 Issue 165 (Thursday, August 26, 1999) (govinfo.gov)}
2. ^{Lykos. Lykos Therapeutics Announces FDA Advisory Committee Meeting to Review Investigational MDMA-Assisted Therapy for PTSD. Press release. Published May 6, 2024. https://news.lykospbc.com/2024-05-06-Lykos-Therapeutics-Announces-FDA-Advisory-Committee-Meeting-to-Review-Investigational-MDMA-Assisted-Therapy-for-PTSD}
3. ^{Derman C. MDMA-Assisted Therapy for PTSD Is Backed by Positive Data. HCPLive. Published April 4, 2024. https://www.hcplive.com/view/mdma-assisted-therapy-for-ptsd-is-backed-by-positive-data}
4. ^{Derman C. MDMA-Assisted Therapy for PTSD Awaits FDA Decision. HCPLive. Published December 21, 2023. https://www.hcplive.com/view/mdma-assisted-therapy-for-ptsd-awaits-fda-decision}