FDA Rejects Application to Accept MDMA-Assisted Psychotherapy
We are living in a mental health crisis that has reached a critical level with more than 350 million people living with PTSD worldwide. Fortunately, a tool exists that can help address the suffering — psychedelic-assisted therapies.–Rick Doblin, PhD.
On August 9, 2024 the FDA announced that it had refused to endorse the use of MDMA (aka Ecstasy or Molly) for MDMA-assisted psychotherapy. The FDA asked for more research to be done to prepare for another evaluation. More on that follows below from the President of the Multidisciplinary Association for Psychedelic Studies (MAPS).
Prior to 1985, MDMA, in its pure form, was a legal substance and could be used legally in a therapeutic context. It was also very popular as a party drug as it reduced inhibitions and typically activated more trust, self-acceptance, and warm feelings towards others. Used by a trained, ethical facilitator in therapy, appropriate use of pure MDMA was found to reduce the effects of PTSD, depression and anxiety, allowing greater insight and freedom from past problems of life. I was one of those trained in the appropriate therapeutic use of MDMA in the early 80s and found it to be an extraordinary support for some people engaged in a healing process. I was very sorry it became illegal to use in 1985.
FDA and MAPS
MAPS president, Rick Doblin, PhD, responded to the FDA announcement via a public letter:
We are living in a mental health crisis that has reached a critical level with more than 350 million people living with PTSD worldwide. Fortunately, a tool exists that can help address the suffering — psychedelic-assisted therapies.
We [MAPS] have made tremendous progress over 38 years in combatting drug war stigma, generating data showing the potential of psychedelic-assisted therapies to treat mental health conditions, and educating the public on how psychedelics can be safely integrated into society. … now, more than half of Americans support legal access to psychedelic-assisted therapies.
Lykos Therapeutics announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for midomafetamine (MDMA) capsules used in combination with manualized therapy for PTSD. The CRL specifies the additional information Lykos will need to provide for the FDA to continue its evaluation. Read more in today’s announcements from Lykos.
We are evaluating MAPS’ path forward to support safe, legal access to the beneficial uses of MDMA and other psychedelics and to global regulatory approval of MDMA-assisted therapy. I remain confident that rigorous science, diligent research, and drug policy reform that catalyzes citizen advocacy will eventually win out on behalf of the millions of people who might benefit.
At MAPS, our journey continues with MDMA and beyond. MAPS is expanding its international therapist training and educational programs and is working with local experts to start a series of small pilot studies in MDMA-assisted individual and group therapy for PTSD in high-trauma/low-resource parts of the world. In the U.S. and in international forums, we’re hard at work advancing research, changing policy, and shaping culture, creating a post-prohibition world where people have legal and equitable access to psychedelics for healing, spirituality, religion, and personal growth.
While we are devastated to see the FDA’s response, today’s news shows us just how urgent our work is. There is still a need for more research to better understand the potential applications and risks associated with psychedelics. There is still a need for policy change at the state and federal levels to increase access. And there is still a need for education to help eliminate stigma and misunderstandings.
[Let’s] create a post-prohibition world where people have legal access to psychedelics for healing and personal growth.…
To Healing for All,
Rick Doblin, PhD
MAPS Founder and President
From an email first sent on August 9, 2024
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