& development

MDMA-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.


MDMA was used in conjunction with talk therapy by mental health providers.

MDMA: A brief history

MDMA (midomafetamine) is commonly known to mental health professionals. In the 1970s and early 1980s, MDMA was used in conjunction with talk therapy by mental health providers to help facilitate patients’ access, processing and communication of difficult emotions and experiences.1 MDMA is an entactogen — a class of psychoactive compounds that are differentiated from classic psychedelics (i.e., psilocybin, mescaline and LSD) and are defined based on their mechanism and known effects of increasing self-awareness leading to introspection and personal reflection.2,3

a graphic that reads "1970s-1980s: mdma was used in conjunction with talk therapy by mental health providers."


U.S. Drug Enforcement Administration (DEA) made MDMA a Schedule I drug

In 1985, the U.S. Drug Enforcement Administration (DEA) made MDMA a Schedule I drug under the Controlled Substances Act, preventing it from being used for recreational or medical use.4 Since then, research has suggested that MDMA may have potential as a catalyst to support psychotherapy by helping diminish the brain’s fear response, allowing people to access and process painful memories without being overwhelmed.5

a graphic that reads "1985: u.s. drug enforcement administration (dea) made mdma a schedule I drug."


FDA granted investigational MDMA-assisted therapy Breakthrough Therapy designation

Lykos, with longstanding roots in advocacy for psychedelic medicine, was the first company to pioneer randomized, double-blind, placebo-controlled clinical trials evaluating the efficacy and safety of MDMA-assisted therapy as an investigational modality using midomafetamine (MDMA) in combination with psychological intervention for adults with PTSD.

With a growing body of data supporting the potential medical use of MDMA, in 2017, the U.S. Food and Drug Administration (FDA) granted our company’s investigational midomafetamine (MDMA) capsules Breakthrough Therapy designation, a process designed to expedite the development and review of drugs intended to treat serious conditions for which preliminary scientific evidence indicates that the drug may demonstrate a substantial improvement over available therapies on clinically significant endpoints.

a graphic that reads "2017: fda granted investigational mdma-assisted therapy breakthrough therapy designation."


New drug application accepted by the FDA and granted priority review

Investigational MDMA-assisted therapy

MDMA-assisted therapy is an investigational modality being studied using midomafetamine (MDMA) capsules in combination with psychological intervention (talk therapy) in adults with post-traumatic stress disorder (PTSD). At Lykos Therapeutics, we have completed two Phase 3 clinical trials of MDMA-assisted therapy for PTSD (MAPP1 and MAPP2), both published in Nature Medicine,6,7 comprised of three investigational treatment cycles, which each consisted of one medication session and three integration sessions. During these medication sessions, a patient self-administered MDMA or placebo under the supervision of at least one qualified healthcare provider who provided therapy and other supportive services. This was followed by three integration therapy sessions, which allowed participants to process what was uncovered during the medication sessions. Prior to the first medication session, there were three preparation sessions to establish a relationship with the therapist. In December 2023, Lykos submitted a new drug application to the FDA, which was accepted and granted priority review in February 2024. If approved by the FDA, this would be the first MDMA-assisted therapy and the first psychedelic-assisted therapy approved for PTSD.

Lykos also conducted the first functional neuroimaging study to evaluate the impact of MDMA-assisted therapy in participants with PTSD, the results of which were published in Frontiers in Psychiatry.8

a graphic that reads "2024: new drug application accepted by the fda and granted priority review."

1. Wagner MT, Mithoefer MC, Mithoefer AT, MacAulay RK, Jerome L, Yazar-Klosinski B, Doblin R. Therapeutic effect of increased openness: Investigating mechanism of action in MDMA-assisted psychotherapy. J Psychopharmacol. 2017 Aug;31(8):967-974. doi: 10.1177/0269881117711712. Epub 2017 Jun 21. PMID: 28635375; PMCID: PMC5544120.
2. Nichols, David E. Entactogens: How the Name for a Novel Class of Psychoactive Agents Originated. Frontiers in Psychiatry. Vol 13, 2022. DOI= 10.3389/fpsyt.2022.863088.
3. Vollenweider, Franz X., Dialogues Clin Neurosci. 2001 Dec; 3(4): 265–279. doi: 10.31887/DCNS.2001.3.4/fxvollenweider.
4. National Institute on Drug Abuse. What is the history of MDMA? | National Institute on Drug Abuse (NIDA) ( Accessed, January 17, 2024. What is the history of MDMA? | National Institute on Drug Abuse (NIDA) (
5. Yazar-Klosinski B, Mithoefer MC. Potential Psychiatric Uses for MDMA. Clinical Pharmacology & Therapeutics, 2016 Nov 9.
6. 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.
7. 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 14 doi: 10.1038/s41591-023-02565-4.
8. Singleton SP et al. Altered brain activity and functional connectivity after MDMA-assisted therapy for post-traumatic stress disorder. Front Psychiatry. 2023 Jan 12;13:947622. doi: 10.3389/fpsyt.2022.947622. PMID: 36713926; PMCID: PMC9879604.