A drug once synonymous with rave culture could soon be making its way into a very different setting: the therapist’s office.
A leading psychedelics advocate is “very optimistic” the Food and Drug Administration could approve MDMA-assisted therapy for post-traumatic stress disorder as early as January.
But even if the treatment gets the green light, a major roadblock could stand between the psychedelic and the millions of Americans who could benefit from a new path to relief.
MDMA, also called ecstasy and molly, is known for its euphoric effects and reputation as a party drug. It has no FDA-approved medical uses, though researchers have spent years exploring whether it could serve as a mental health treatment — with promising results.
In a 2021 clinical trial conducted by the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS), people with PTSD who received MDMA alongside psychotherapy were twice as likely to recover as those who received psychotherapy with a placebo.
PTSD, which can develop after experiencing or witnessing a traumatic event, can leave sufferers battling flashbacks, nightmares, severe anxiety and intrusive thoughts, according to the Mayo Clinic.
For patients who’ve exhausted traditional options, advocates have argued that MDMA-assisted therapy could offer a new lifeline.
Yet the road to approval has been anything but a smooth ride.
Two years ago, Lykos Therapeutics looked like a frontrunner to bring MDMA into mainstream medicine.
Then, in August 2024, the FDA dashed those hopes, rejecting the company’s application over questions about the reliability of its clinical trial data, potential safety risks and concerns that the studies didn’t adequately demonstrate the therapy’s effectiveness.
The agency called for another Phase 3 trial to help address those apprehensions.
The decision dealt a major blow to psychedelic researchers, patient advocates and veterans’ groups who’d championed the drug. Had it been approved, it would have marked the first new PTSD therapy in more than two decades.
Rick Doblin — MAPS founder and former board member of Lykos, formally known as the MAPS Public Benefit Corporation — said there had been warning signs before the FDA’s decision.
“Leading up to 2024, I saw a variety of ways in which the management of the company was not responding to the culture, not responding to the critics, not doing proactive things that they needed to do,” Doblin told The Post, describing the saga as a “slow-motion train wreck.”
“I still was surprised that the FDA advisory committee said no and the FDA rejected it,” he noted.
Now, new hope is on the horizon.
In August, Resilient Pharmaceuticals, formerly known as Lykos Therapeutics, reportedly resubmitted its application to the FDA. Notably, the filing did not include the additional Phase 3 trial the agency had previously requested.
Instead, the company cited research conducted by other groups, including a small Veterans Affairs study with long-term follow-up, according to Psychedelic Alpha, which first reported the resubmission.
MAPS confirmed the news, though Resilient hasn’t publicly commented on it. Resilient could not be reached by publication time.
This time around, Doblin thinks the odds are looking good.
“The FDA has sort of put all their concerns on the table, and the company has addressed all those concerns, and the FDA has permitted the new drug application to go forward without another Phase 3 study — that was such a big thing,” he explained.
There are other reasons for optimism, too.
Health and Human Services Secretary Robert F. Kennedy Jr. has expressed support for the expedited research and approval of psychedelic therapies for clinical use, potentially bolstering their prospects.
In April, President Trump signed an executive order directing federal agencies to ramp up psychedelic research. The FDA also issued priority review vouchers to three companies developing psychedelic-based mental health treatments.
“A bigger thing, just from a cultural acceptance point of view, is that the Department of Defense is doing studies with active duty soldiers with PTSD with MDMA-assisted therapy,” Doblin noted.
“I think there’s way more excitement now inside the VA,” he continued. “Plus, you have the entry of big pharma buying up all these companies, which we didn’t have in 2024.”
That includes Eli Lilly, which acquired AtaiBeckley in July for $2.8 billion, gaining access to a pipeline that includes programs based on MDMA.
“I think it’s a completely different situation now,” Doblin said.
At last week’s Beyond Psychedelics Conference in Austin, Texas, Doblin took that optimism to the stage, telling an audience at famed biohacker Dave Asprey’s event there’s a “very good chance” Resilient’s application will be approved by the end of the first quarter of 2027.
His prediction drew cheers from the crowd, a mix of psychedelic researchers, industry insiders and everyday enthusiasts.
“I would say that I’m very optimistic,” he told The Post backstage. “But I’m willing to be disappointed — and we’ll keep trying.”
The FDA declined to comment on the status of the application.
“Under the law, the FDA is able to provide information on approved product applications. Information on an application that has not been approved, including an application yet to receive approval, generally is not releasable,” a spokesperson for the agency said in a statement to The Post.
Even if MDMA clears the regulatory hurdles, another obstacle could throw a wrench in its path to patients: a shortage of qualified therapists that Doblin said is “really acute.”
“The amount of people who need this is astronomical,” he noted. “The VA has estimated there’s 13 million people in America with PTSD — so we have nowhere near the number of therapists we need.”
And Doblin isn’t the only one sounding the alarm.
“Let’s just say we’re already behind,” said Dr. Dave Rabin, a trained MDMA psychotherapist and neuroscientist who studies psychedelics as potential mental health treatments.
“We really need to buckle ourselves in and get ready to create the infrastructure needed for continuing medical education programs,” he told The Post. “That’s the biggest challenge we’re going to have to overcome moving forward — other than insurance reimbursement.”
MAPS is among those working to address the shortage, with the nonprofit planning to hold its first US training in December.
“I think that once it’s approved, there’s going to be even more pressure to expand rapidly because the need is so great,” Doblin said. “But we should be very careful to expand only at the rate that we’ve got qualified therapists.”