SAN JOSE, Calif., May 6, 2024 /PRNewswire/ -- Lykos Therapeutics (formerly MAPS Public Benefit Corporation) ("Lykos"), a company dedicated to transforming mental healthcare, announced that on June 4, 2024, the U.S. Food and Drug Administration's ("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.1 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.
"This will be the first MDMA-assisted therapy and psychedelic-assisted therapy to be reviewed by the Psychopharmacologic Drugs Advisory Committee, a significant milestone in the field of psychedelic medicine, resulting from decades of clinical research and advocacy," said Amy Emerson, Chief Executive Officer of Lykos Therapeutics. "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."
PDAC will review results from numerous studies including two randomized, double-blind, placebo-controlled Phase 3 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.2,3
On February 9, 2024, the FDA accepted the company's NDA for midomafetamine used in combination with psychological intervention for adults with PTSD. The FDA granted the application Priority Review and has assigned a Prescription Drug User Fee Act ("PDUFA") target action date of August 11, 2024. The FDA grants Priority Review for drugs that, if approved, would represent significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.4 If approved, this would be the first MDMA-assisted therapy and psychedelic-assisted therapy.
Midomafetamine (MDMA) capsules have not been approved by any regulatory agency. The safety and efficacy of midomafetamine have not been established for the treatment of PTSD. Investigational midomafetamine is also being studied in other indications.
Lykos Therapeutics
At Lykos Therapeutics, a public benefit corporation (PBC) founded by MAPS, our mission is to transform mental healthcare. We're applying decades of evidence-based research to develop investigational psychedelics to catalyze therapeutic approaches for mental health conditions. We are relentlessly exploring and reimagining novel approaches to address unmet needs in the mental healthcare space, with an initial focus on PTSD. As a PBC, we are focused on delivering positive impact on our people, communities and society. To learn more visit us at www.lykospbc.com and on LinkedIn, X, Instagram and Facebook.
1 FDA, Federal Register. Accessed April 2024. Federal Register, Volume 64 Issue 165 (Thursday, August 26, 1999) (govinfo.gov)
2 Mitchell JM, Bogenschutz M, Lilienstein A, et al. MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nat Med. 2021 Jun;27(6):1025-1033. doi: 10.1038/s41591-021-01336-3
3 Mitchell JM, Ot'alora MG et al. MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nat Med. 2023 Sept;29: 2473–2480. doi: 10.1038/s41591-023-02565-4
4 FDA Priority Review. Accessed April 2024. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review.
SOURCE Lykos Therapeutics