MDMA-assisted therapy has not been approved by any regulatory agency. The safety and efficacy of MDMA-assisted therapy have not been established for the treatment of PTSD.
Advancing medical and scientific knowledge in clinical research
We are committed to conducting research to determine the safety and efficacy of our investigational products to determine their potential to help address unmet needs in mental health. We have completed two Phase 3 trials for PTSD and submitted a new drug application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for MDMA (midomafetamine capsules) used in combination with psychological intervention, which includes talk therapy, and other supportive services provided by a qualified healthcare provider. Investigational MDMA-assisted therapy is in development for individuals with post-traumatic stress disorder (“PTSD”) and if approved, would be the first psychedelic-assisted therapy approved for PTSD.1, 2 We have completed six Phase 2 and two Phase 3 studies examining the use of investigational MDMA-assisted therapy for PTSD. MDMA-assisted therapy is also being studied in other indications.
Investigator-initiated trials and studies
In addition to advancing the medical and scientific knowledge of Lykos’ investigational therapies, we provide support for external clinical research in areas that help discover new opportunities to address unmet medical needs. We will consider applications proposing to investigate 3,4-methylenedioxymethamphetamine (MDMA).
To submit your research concept, please visit our online portal and click on the link below.
To learn more about ongoing studies with investigational MDMA-assisted therapy, please visit clinicaltrials.gov.
1. Mitchell JM et al. Nat Med. 2021;27(6):1025-1033.
2. MAPS PBC Announces Positive Results from Confirmatory Phase 3 “MAPP2” Trial of MDMA-Assisted Therapy for Treatment of PTSD – MAPS Public Benefit Corporation (mapsbcorp.com). Accessed July 3, 2023.