We were this close to seeing Ecstasy being incorporated into therapy in the US in 2024. Now, we have to wait either a little or a lot – depending on how the chips fall. Let's have a closer look at where we're currently at.
Wait, we were going to get Ecstasy for therapy?
Well, to be clear, you wouldn’t get the party drug version of Ecstasy, aka Molly, aka MDMA, aka 3,4‑methylenedioxy‑methamphetamine, for just any reason. You’d get a similar concoction of the compound formulated for assisted therapy to treat post-traumatic stress disorder (PTSD).
A licensed therapist would guide you through sessions that combined talk therapy with use of the empathogen, to help you deal with your condition in a safe environment.
Activists have been advocating for MDMA in therapy for roughly two decades now, but getting it approved has been a struggle. It was classified as a Schedule 1 drug in the US (read: illegal) in the 1980s. That has kept it out of reach for any sort of clinical or recreational use since it made a splash in the 70s as a party drug.
How does MDMA help treat PTSD?
PTSD is an awful condition to go through. It’s responsible for intense fear and crippling panic attacks brought on by traumatic memories. It’s worryingly common among military veterans: 7 out of every 100 Veterans will have PTSD.
MDMA stimulates the release of a mood-regulating neurotransmitter called serotonin. That then releases oxytocin, which is responsible for feelings of closeness.
"MDMA can allow you to process deep-seated trauma by enabling the transformation of fear memories in a part of the brain called the amygdala in a manner that doesn’t make you withdraw or detach out of shame or fear, but instead helps you to accept and heal," explains Jennifer Mitchell, PhD, professor of neurology and of psychiatry and behavioral sciences at University of California, San Francisco.
What’s the holdup?
In many cases, the US has been known to lead the charge in permitting the use of drugs in various treatments, with other countries following suit. The FDA’s drug approval process is known to be stringent: new drug applications can take between 12-15 years to go through the necessary testing and get approved.
About 13 million US adults were estimated to suffer from PTSD as of 2020, and there have been no new medications approved by the FDA to treat the condition in 25 years. So yeah, this was a high-stakes situation.
What just happened?
On August 9, Lykos Therapeutics, a US-based drug maker, said its application to the FDA to allow the use of MDMA for treatment of PTSD was not approved. The agency, for its part, "determined that it could not be approved based on data submitted to date," and asked Lykos to conduct an additional Phase 3 trial to make its case.
That’s a crushing blow to the effort to legitimize MDMA for medicinal use in the US – particularly after the application’s FDA review was slated to be fast tracked so it’d take place within six months.
This follows the concerns that arose from a FDA advisory committee meeting to review Lykos’ trials in June. A panel of experts wasn’t convinced the clinical trial was designed to appropriately establish placebo controls in the study.
In other words, the panel questioned whether it was truly possible to 'blind' people in the study and remove bias in their response to receiving treatment – whether they received MDMA or an inactive placebo.
That committee then voted 9-2 that there was insufficient evidence to support Lykos’ prescribed treatment.
There’s more. Just a day after the FDA’s decision came to light, Psychopharmacology – an international journal that publishes research on how drugs impact human cognition – retracted three Lykos studies on MDMA therapy that appeared in 2020, citing "unethical conduct at the [MP4] study site by researchers associated with this project."
What happens now?
Following the 1-2 punch that Lykos just took on the chin, it’s likely not going to be easy to make MDMA-assisted therapy a reality in the US soon.
Lykos will appeal the decision, but if that doesn’t go through, its only option is to conduct another Phase 3 trial – the last major step before a new drug application is submitted for approval – which the company has said "will take several years."
Hope down under
Australia has surprisingly taken the lead in allowing MDMA to be used in therapy.
Last July, its government authorized psychiatrists to prescribe MDMA for PTSD, and psilocybin (found in magic mushrooms) for treatment-resistant depression (TRD).
Of course, it’s not exactly an over-the-counter situation. Psychiatrists must first apply to become Authorized Prescribers following drug agency guidelines. And even then, it’s classified as a scheduled drug for only these specific conditions.
Beyond having psychiatrists go through several hoops before they can prescribe these drugs, it’s also worth noting that MDMA treatment ain’t cheap or quick.
Clarion Clinics, which opened in January in a suburb of Melbourne, offers MDMA-assisted treatment over the course of nine months. That includes just two dosing sessions, with several screenings before, and lots of psychotherapy in between and after.
A treatment package will set you back by up to AUD 27,500 (which converts to around US$18,200).
As The Guardian noted in its piece on the clinic in February, there are still several unknowns as to the best sort of patient for this treatment, and how it will play out through the course of treatment and beyond.
Until that’s all worked out – and treatments can be streamlined, if that’s even possible – MDMA-assisted therapy for PTSD might only be available to a small sliver of the population suffering from this condition.