MAPS Statement on FDA Complete Response Letter for MDMA-Assisted Therapy for PTSD New Drug Application
August 09 2024 - 9:33PM
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.
NOTEThe 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 MAPSFounded 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
CONTACTmedia@maps.org