A drug that once defined rave culture might soon find its way into a more therapeutic environment: the therapist’s office.
A major advocate for psychedelics is quite hopeful that the Food and Drug Administration will approve MDMA-assisted therapy for post-traumatic stress disorder as soon as January.
However, even if approval happens, there’s a significant hurdle that could obstruct access to this treatment for millions of Americans in need of a new form of relief.
MDMA, known as ecstasy or molly, is famous for its euphoric effects and reputation as a party drug. Despite having no FDA-approved medical applications, researchers have explored its potential as a mental health treatment with encouraging results.
In a 2021 clinical trial led by the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS), participants with PTSD who underwent MDMA therapy alongside psychotherapy had double the chances of recovery compared to those who received psychotherapy with a placebo.
PTSD can arise after one experiences or witnesses a traumatic event and may result in flashbacks, nightmares, severe anxiety, and intrusive thoughts, according to the Mayo Clinic.
Patients who have exhausted conventional treatments have found advocates arguing that MDMA-assisted therapy could provide a vital lifeline.
Nevertheless, the journey to get this therapy approved has been quite rocky.
Two years ago, Lykos Therapeutics seemed poised to pave the way for MDMA in mainstream medicine.
Then, in August 2024, the FDA dashed those hopes, rejecting their application due to concerns regarding the reliability of clinical trial data, potential safety issues, and doubts that the studies sufficiently proved the therapy’s effectiveness.
The agency called for another Phase 3 trial to address those concerns.
This rejection was a significant setback for psychedelic researchers, patient advocates, and veteran groups that supported the drug. Had it been approved, it would have introduced the first new PTSD therapy in over two decades.
Rick Doblin, the founder of MAPS and a former board member of Lykos, indicated that signs of trouble were evident before the FDA’s decision.
“As we approached 2024, I noted various ways the company’s management was not responding to culture or criticism, not proactive in the necessary areas,” Doblin remarked, describing the situation as a “slow-motion train wreck.”
“I was still taken aback by the FDA advisory committee’s rejection,” he acknowledged.
Now, however, there’s renewed hope.
In August, Resilient Pharmaceuticals, formerly Lykos Therapeutics, reportedly resubmitted its application to the FDA. Notably, this time around, it didn’t include the extra Phase 3 trial that the agency had initially requested.
Instead, the company referenced studies conducted by other entities, including a small Veterans Affairs study that featured long-term follow-up results, as reported by Psychedelic Alpha, which first shared the news of the resubmission.
MAPS confirmed the news, but Resilient has not made any public statements on it yet. The company was unreachable for comments prior to publication.
This time, Doblin believes the outcome might be favorable.
“The FDA has outlined their concerns, and the company has addressed them. The FDA has allowed the new application to proceed without requiring another Phase 3 study, which is a significant development,” he elaborated.
Additional reasons for optimism are emerging as well.
Health and Human Services Secretary Robert F. Kennedy Jr. has shown support for speeding up research and approval processes for psychedelic therapies, endorsing their potential clinical usage.
Earlier this year, President Trump signed an executive order to accelerate psychedelic research, and the FDA has awarded priority review vouchers to three companies that are working on psychedelic-based mental health therapies.
“From a cultural acceptance standpoint, it’s worth noting that the Department of Defense is conducting studies with active duty soldiers using MDMA-assisted therapy for PTSD,” Doblin remarked.
“There’s much more enthusiasm within the VA now,” he added. “Also, many large pharmaceutical companies are investing in this area, which wasn’t the case back in 2024.”
For instance, Eli Lilly acquired AtaiBeckley in July for $2.8 billion, gaining access to programs that include MDMA-based treatments.
“The landscape is certainly different now,” Doblin remarked.
At the recent Beyond Psychedelics Conference in Austin, Texas, Doblin shared this positive outlook with an audience at biohacker Dave Asprey’s event, conveying that there’s a “very good chance” Resilient’s application could receive approval by the close of the first quarter of 2027.
His optimistic forecast incited cheers from a crowd comprising psychedelic researchers, industry participants, and everyday enthusiasts.
“I’d say I’m very optimistic,” he told The Post after his speech. “Yet, I’m also prepared for disappointment — we’ll keep pushing forward.”
The FDA opted not to comment on the application’s current status.
“Legally, the FDA can only disclose information regarding approved product applications. Details concerning applications that have not yet been approved are generally not available,” a spokesperson for the agency shared in a statement to The Post.
Even if MDMA clears regulatory challenges, another significant issue could obstruct its delivery to patients: a severe shortage of qualified therapists, which Doblin described as “really acute.”
“The demand is staggering,” he pointed out. “The VA estimates around 13 million individuals in the U.S. have PTSD — we do not have nearly enough therapists to meet this need.”
And Doblin’s concerns are echoed by others.
“To put it bluntly, we’re already behind,” stated Dr. Dave Rabin, a trained MDMA psychotherapist and neuroscientist investigating the use of psychedelics for mental health treatments.
“We need to prepare ourselves to develop the necessary infrastructure for continuing medical education programs,” he advised The Post. “That’s going to be our biggest hurdle moving forward — along with issues around insurance reimbursement.”
MAPS is also addressing the shortage, planning to conduct its first U.S. training in December.
“I believe that once approval is granted, the urgency to expand quickly will grow, given the substantial need,” Doblin opined. “But we must be cautious, expanding only at a pace that matches the availability of qualified therapists.”
