MAPS Statement on FDA Complete Response Letter for MDMA-Assisted Therapy for PTSD New Drug Application

• MAPS remains confident in its goal of making access to MDMA-assisted therapy for PTSD safe and legal

SAN JOSE, Calif., Aug. 09, 2024 (GLOBE NEWSWIRE) — The Multidisciplinary Association for Psychedelic Studies (MAPS) is evaluating the path forward for safe, legal access to MDMA-assisted therapy following the announcement from Lykos Therapeutics that the potential approval of midomafetamine (MDMA) capsules used in combination with therapy for PTSD will be delayed by FDA.

Read Lykos’ announcement about the CRL and next steps.

MAPS and our supporters have been advocating for the development and supporting the FDA-approved research of MDMA-assisted therapy for more than 38 years; MAPS will continue working towards safe, legal access to this therapy for the more than 350 million people living with PTSD worldwide.

Our collective commitment to MDMA-assisted therapy remains unwavering. MAPS remains fully focused on supporting culturally appropriate research, rigorous science, and drug policy reform that empowers citizen advocacy in all areas of the world including those with high incidences of trauma and limited resources.
Rick Doblin, PhD, Founder and President of MAPS

MAPS’ strategic agenda, adopted by the Board of Directors, is to shepherd a post-prohibition world where people have legal and equitable access to psychedelics for healing and personal growth. We do that by:

• Advancing Research by incubating, informing, and inspiring research that enables new investigative directions, improves patient access and experience, and informs data-driven drug policy and education.
• Changing Policy toward a harmonious drug policy ecosystem that balances public health, individual liberty, and equitable access across a variety of regulatory approaches.
• Shaping Culture with accurate, evidence-based, and balanced education for professionals and the public and convening experts at events such as Psychedelic Science 2025.

Since our founding in 1986, MAPS has been a leading organization building the movement to foster evidence-based approaches to psychedelics and the people who use them. Learn more and sign up for email updates at maps.org.

NOTE
The safety and efficacy of psychedelic-assisted therapies are currently under investigation. Neither midomafetamine (MDMA)-assisted therapy for PTSD, nor any other psychedelic-assisted therapy, has been established for the treatment of any mental health condition. No treatment works for everyone; all treatments, even in clinical settings, carry risks.

ABOUT MAPS
Founded in 1986, MAPS is a 501(c)(3) nonprofit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. MAPS previously sponsored the most advanced psychedelic-assisted therapy research in the world and continues to support psychedelic and marijuana research with a focus on the people and places most impacted by trauma. MAPS incubated Lykos Therapeutics, a drug-development public benefit company, and The Zendo Project, a leader in psychedelic harm reduction. Since MAPS was founded, philanthropic donors and grantors have given more than $140 million to advance psychedelic research, change drug policy, and shape culture.

MEDIA CONTACT
media@maps.org