MDMA Therapy Could Be Re-Legalized this Year: An Interview with Rick Doblin
Rick Doblin of MAPS Provides Update on MDMA-Assisted Therapy for PTSD
Dear Friends,
Last week I celebrated my 85th birthday with close friends at the Health Sanctuary I created in 1972 at Wilbur Hot Springs in northern California.
Among my guests was my dear friend and colleague Dr. Rick Doblin—the founder of the Multidisciplinary Association for Psychedelic Studies (MAPS). Rick give me an update on what's going on both with MAPS – the nonprofit that he started in 1986 – and Lykos Therapeutics, the public benefit for-profit pharmaceutical company that MAPS started in 2014.
It appears that we are on the verge of an unprecedented breakthrough in the field of psychedelic medicine, with the potential approval of MDMA-assisted therapy for treatment of PTSD.
Below is an edited transcript of our conversation, which you can also watch:
Rick Doblin: Today, Lykos Therapeutics is in a great position. It took us from 1986, almost 38 years, to gather all the data needed to submit a new drug application to the FDA for MDMA-assisted therapy for PTSD. That application was submitted on December 11th, 2023. On February 9th, we were told that all the information was presented and we were granted priority review, which means the FDA recognizes this as a breakthrough therapy. The FDA will have until August 11th to review the application from Lykos Therapeutics and decide whether to approve MDMA-assisted therapy for PTSD for prescription use.
We're quite hopeful it will be approved based on the excellent statistical significance, large effect size, and strong safety data from our trials. FDA has also recently conducted audits of our data gathering process. After this 39 years of criminalization since MDMA was banned in 1985, taking away both recreational and therapeutic use, we think we're about to finally bring back MDMA for therapeutic purposes. While the approval will be joyous, it's also tragic to think of all the suffering, suicides, and people that could have been helped in the meantime had MDMA never been made illegal.
After this 39 years of criminalization, we think we're about to bring back MDMA for therapeutic use.
However, FDA approval alone is not enough to get this treatment to patients. The Drug Enforcement Administration has 90 days after approval to decide how to reschedule MDMA from Schedule I, meaning no medical use, to Schedule III for this specific encapsulated medical product. This bifurcated scheduling would keep MDMA as Schedule I outside of the approved medical use.
MAPS' Future Plans: Israel, Canada, and Global Expansion
As a nonprofit, MAPS will look to expand access to MDMA-assisted therapy for PTSD in high trauma, low resource areas around the world where people are suffering but may not have the resources to pay. We're also interested in exploring more group therapy options and potentially working with traumatized refugee and migrant families to treat them as a unit.
Our phase 3 studies took place in the US, Canada and Israel. The Ministry of Health in Israel and Health Canada are likely to follow the FDA's lead, as it is the major drug regulatory agency in the world alongside the European Medicines Agency. While many countries are willing to "go second", few want to be first. An FDA approval could open the door for research and therapeutic use in places like Australia, England, Brazil and other countries.
To join our mailing list, donate, or learn more, visit maps.org. We're looking to build our membership base as we pioneer new areas like MDMA for couples therapy, which I saw phenomenal results with before MDMA was banned in 1985. We're also interested in using MDMA for conflict resolution. These applications may require establishing new regulatory pathways. We've been informed by several people inside the FDA that there's nothing preventing them from approving MDMA-assisted therapy for couples, but there's no existing regulatory examples of something like that happening.
Dr. Richard L. Miller: Based on what I professionally witnessed before MDMA was made illegal in 1985, the effects, especially when used in couple therapy was phenomenal. It will be extremely helpful when this medicine be federally approved for use. So I'll be checking in with you on the 12th of August to find out the results of the inquisition and an update for our listeners.
Until next time, this is Dr. Richard Louis Miller reminding you that good health is worth fighting for and it's essential for life, liberty and the pursuit of happiness.
Watch my recent episode with Dr. Robin Carhart-Harris
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My Books
Freeing Sexuality: Psychologists, Consent Teachers, Polyamory Experts, and Sex Workers Speak Out
Psychedelic Wisdom: The Astonishing Rewards of Mind-Altering Substances
Psychedelic Medicine: The Healing Powers of LSD, MDMA, Psilocybin, and Ayahuasca
Integral Psychedelic Therapy (co-edited with Jason A. Butler & Genesee Herzberg)