FDA Advisory Committee meeting to review investigational MDMA-assisted therapy for PTSD
Lykos Therapeutics (formerly MAPS Public Benefit Corporation) announced that on June 4, 2024, the FDA Psychopharmacologic Drugs Advisory Committee ("PDAC") will review data supporting the new drug application ("NDA") for midomafetamine (MDMA) capsules used in combination with psychological intervention ("MDMA-assisted therapy") for adults with post-traumatic stress disorder ("PTSD")
This will be the first FDA advisory committee meeting to review a potential new PTSD treatment in 25 years. As with all advisory committee meetings, there will be an open public hearing (OPH) session, during which interested persons may present relevant information or views orally or in writing.
The PDAC will review results from numerous studies including two randomized, double-blind, placebo-controlled Phase III studies (MAPP1 and MAPP2) evaluating the efficacy and safety of MDMA used in combination with psychological intervention, which includes psychotherapy (talk therapy) and other supportive services provided by a qualified healthcare provider, versus placebo with psychological intervention in participants diagnosed with severe or moderate to severe PTSD, respectively. Both MAPP1 and MAPP2 studies met their primary and secondary endpoints and were published in Nature Medicine.
See-Published: 14 September 2023; "MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase III trial": Jennifer M. Mitchell, Marcela Ot’alora G., Bessel van der Kolk, Scott Shannon, & MAPP2 Study Collaborator Group. Nature Medicine volume 29, pages2473–2480 (2023)
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