It seems we were this close to Ecstasy being legalized as a therapy in the US in 2024. Now, we either have to wait a little longer or a long time—however that may play out. Let’s take a closer look at where we are now.
Wait, were we supposed to take Ecstasy for therapy?
Yes. To be clear, you can’t take the party drug version of Ecstasy, aka Molly, or MDMA, aka 3,4‑methylenedioxy‑methamphetamine, for any reason. You’re taking a similar blend of the compound formulated for adjunctive therapy to treat post-traumatic stress disorder (PTSD).
A licensed therapist will help you cope with your condition in a safe environment by guiding you through sessions that combine the use of empathy-building with talk therapy.
Activists have been advocating for MDMA in therapy for nearly two decades, but it has had a hard time getting approval. It was classified as a Schedule 1 drug (read: illegal) in the U.S. in the 1980s, making it inaccessible for any clinical or recreational use since it hit the big time as a party drug in the ’70s.
How does MDMA help treat PTSD?
PTSD is a terrifying condition to go through. It’s responsible for intense fear and paralyzing panic attacks caused by memories of the trauma. It’s alarmingly common among military veterans: 7 in 100 veterans have PTSD.
MDMA stimulates the release of a mood-regulating neurotransmitter called serotonin, which in turn releases oxytocin, which is responsible for feelings of closeness. That's part of what makes it a wonder drug for ravers.
“MDMA can help you cope with deep-seated trauma by enabling fear memories to be transmuted in a part of the brain called the amygdala in a way that doesn’t cause you to withdraw or disconnect out of shame or fear, but instead helps you accept and heal,” explains Jennifer Mitchell, MD, professor of neurology, psychiatry, and behavioral sciences at the University of California, San Francisco.
What's the delay?
It is known that in many cases, the US has been a pioneer in authorizing the use of drugs for various treatments, and other countries have followed suit. The FDA's drug approval process is known to be stringent: new drug applications can take 12-15 years to undergo the necessary testing and be approved.
As of 2020, an estimated 13 million U.S. adults suffered from PTSD, and there had been no new FDA-approved drugs to treat the condition in 25 years. So yes, this was a high-risk condition.
What happened now?
On August 9, Lykos Therapeutics, a U.S.-based drugmaker, said its application to the FDA to allow the use of MDMA to treat PTSD was not approved. The agency, for its part, determined that it “cannot be approved based on the data presented to date” and asked Lykos to conduct an additional Phase 3 trial to support its case.
This was a severe blow to efforts to legitimize medical use of MDMA in the U.S., especially after the application was scheduled to be expedited for FDA review within six months.
This follows concerns that arose from an FDA advisory committee meeting in June to review Lykos' trials. A panel of experts was not convinced that the clinical trial was designed to appropriately include placebo controls in the study.
In other words, the panel questioned whether it was really possible to 'blind' people in the study and eliminate bias in their response to treatment – whether they received MDMA or an ineffective placebo.
That committee later voted 9-2 that there was insufficient evidence to support the treatment Lykos prescribed.
There's more. Just one day after the FDA's decision was announced, Psychopharmacology – An international journal that publishes research on how drugs affect human cognition – has retracted three Lykos studies on MDMA therapy published in 2020, citing “unethical conduct” [MP4] “Area of study conducted by researchers associated with this project.”
So what happens now?
After the one-two punch Lykos has taken, it looks like MDMA-assisted therapy won't be a reality in the U.S. anytime soon.
Lykos will appeal the decision, but if that appeal is not accepted, its only option is to conduct another Phase 3 trial, the last major step before a new drug application is submitted for approval. The company said this would “take several years.”
There is hope below
Australia has surprisingly taken the lead in allowing MDMA for use in therapy.
Last July, the government authorized psychiatrists to prescribe MDMA for post-traumatic stress disorder (PTSD) and psilocybin (found in magic mushrooms) for treatment-resistant depression (TRD).
Of course, this isn't exactly an over-the-counter situation. Psychiatrists must first apply to become Authorized Prescribers, following drug agency guidelines. And even then, it's only classified as a scheduled drug for those specific conditions.
In addition to the many hurdles psychiatrists have to go through before they can prescribe these drugs, it's also worth noting that MDMA treatment is not cheap or quick.
Clarion Clinics, which opened in a Melbourne suburb in January, offers MDMA-assisted treatment over nine months, which involves just two dosing sessions, a few scans beforehand and lots of psychotherapy in between and afterwards.
A treatment package will cost you up to AU$27,500 (equivalent to approximately US$18,200).
Like Protector As he noted in his February article about the clinic, there are still a few unknowns about who is the best patient for this treatment and what the course and outcome of the treatment will be.
Until all of this is resolved and treatments are simplified (if such a thing is possible), MDMA-assisted PTSD treatment will only be applicable to a small segment of the population suffering from the condition.