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First synthesized in 1912, MDMA’s history is long and varied. In the 1940s, the U.S. Army conducted classified MDMA tests as part of its chemical warfare research program, while the 1970s saw it being introduced to psychotherapy.[1] The drug’s success among patients—reducing their fear response and facilitating emotional breakthroughs—led to increased recreational use in the 1980s.

            While therapists and psychiatrists advocated for MDMA’s continued legal status due to its perceived therapeutic benefits, in 1984 the U.S. Drug Enforcement Administration (DEA) classified MDMA as a Schedule I substance under the Controlled Substances Act, effectively ending its legal medical use.[2]

            Three decades later, MDMA is still making headlines. On Friday, August 9, 2024, Lykos Therapeutics received notification from the U.S. Food and Drug Administration (FDA) that its New Drug Application (NDA) for MDMA-assisted therapy for PTSD had not been approved.[3] According to the statement released by Lykos Therapeutics, FDA requested further studies to evaluate the treatment’s safety and efficacy. Lykos Therapeutics also noted the issues raised in the decision by FDA echoed the concerns raised during the Psychopharmacologic Drug Advisory Committee meeting held on June 4, 2024. To understand how FDA arrived at its decision, it is important to take into consideration 1) the regulatory history between Lykos Therapeutics and FDA; 2) the clinical data provided by Lykos Therapeutics in support of its New Drug Application to FDA; and 3) the key issues expressed by the Advisory Committee and FDA during the June 4th, 2024 Advisory Committee hearing.[4]

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[1] Myron Stolaroff (1997). The Secret Chief Revealed: Conversations with Leo Zeff, Pioneer in the Underground Psychedelic Therapy Movement. Multidisciplinary Association for Psychedelics Studies (MAPS).

[2] George Greer & Requa Tolbert, Subjective Reports of the Effects of MDMA in a Clinical Setting. Journal of Psychoactive Drugs 18(4), 319–327 (1986), https://doi.org/10.1080/02791072.1986.10472364.

[3] Lykos Therapeutics. Lykos Therapeutics Announces Complete Response Letter for Midomafetamine Capsules for PTSD, https://news.lykospbc.com/2024-08-09-Lykos-Therapeutics-Announces-Complete-Response-Letter-for-Midomafetamine-Capsules-for-PTSD, (content current as of August 9, 2024).

[4] United States Food and Drug Administration. UPDATED MEETING TIME AND PUBLIC PARTICIPATION INFORMATION: June 4, 2024: Meeting of the Psychopharmacologic Drugs Advisory Committee Meeting Announcement, https://www.fda.gov/advisory-committees/advisory-committee-calendar/updated-meeting-time-and-public-participation-information-june-4-2024-meeting-psychopharmacologic, (content current as of June 4, 2024) [hereinafter FDA, UPDATED MEETING].