Millions of people living with post-traumatic stress disorder (PTSD) in the United States may soon have the option to get MDMA — also known as ecstasy or molly — prescribed to them as part of their treatment.
The public benefit company Lykos Therapeutics submitted a new drug application late last year to the U.S. Food and Drug Administration (FDA) for its MDMA capsules, to be used alongside therapy to treat PTSD. The FDA fast-tracked the application, granting it priority review in February and giving itself an August deadline to make a decision on whether to approve the first-of-its-kind treatment.
As part of its review, the agency has called in an independent panel of experts to weigh in on the experimental treatment’s safety and efficacy.
On Tuesday the FDA’s Psychopharmacologic Drugs Advisory Committee is set to review — in an all day session — results from numerous studies, including two late-stage clinical trials by Lykos, and give the agency a non-binding recommendation.
“In addition to being the first FDA advisory committee meeting to review a potential new PTSD treatment in 25 years, this will be the first MDMA-assisted therapy and psychedelic-assisted therapy to be reviewed by an FDA advisory committee,” Lykos CEO Amy Emerson told Quartz via email.
If approved, Lykos MDMA treatment would further legitimize a growing wave of interest and funding going toward research into the use of psychedelics to treat mental disorders such as PTSD and depression.
Previously, the FDA approved a nasal spray in 2019 that contains a variation of ketamine for treatment-resistant depression.
What is Lykos Therapeutics?
Lykos is a public benefit corporation that spun-off from the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) in 2014 to bring MDMA-assisted therapy to market.
MAPS itself was founded by activist Rick Doblin in 1986 and has raised over $140 million for psychedelic research and education. Earlier this year, Lykos changed its name from MAPS Public Benefit Corporation when it announced it had raised over $100 million in funding from outside investors.
How does MDMA-assisted therapy work?
Lykos has outlined how its MDMA-assisted therapy for PTSD works in two phase 3 clinical trials.
In the studies, patients were given MDMA capsules made by Lykos along with talk therapy in three eight-hour session, overseen by two specially-trained therapists. The sessions were spread about four weeks apart.
According to results from the latest trial, about 71% of participants who received MDMA-assisted therapy no longer met the criteria for PTSD after 18 weeks, compared with 48% of the patients who received a placebo.
Does the FDA have any concerns?
On Friday, the FDA gave the first hint of its thinking in briefing papers posted online ahead of Tuesday’s meeting.
FDA scientists said that based on the clinical trial data “participants appear to experience rapid, clinically meaningful, durable improvement in their PTSD symptoms.” However they also said the data was “challenging to interpret” due to the nature of the treatment.
Because MDMA produces in alterations in mood and cognition, patients know if they received the treatment or a placebo, making it nearly impossible to carry out a double-blind study.
In March, the Institute for Clinical and Economic Review published a report with similar criticisms of the trials.
Emerson told Quartz that the studies were designed in collaboration with the FDA.
“Given the novel nature of midomafetamine (MDMA) treatment, Lykos has consistently sought and received feedback from the FDA throughout the development program,” Emerson said.
What happens if Lykos’s treatment is approved?
If Lykos’s treatment is approved, the U.S. Drug Enforcement Agency will first need to reschedule MDMA from a Schedule I substance before it can be marketed. The agency will have three months from the time the treatment is approved to do so, with individual states following suit.
As Lykos prepares to take its treatment outside of a clinical setting, the company is planning to offer training programs on how to properlu administer the treatment. Emerson said that, if approved in August, the company plans to launch MDMA-assisted therapy in the first quarter of 2025.
The company will also continue researching other uses for its treatment.