The Food and Drug Administration is considering approving the use of MDMA, also known as ecstasy, for the treatment of post-traumatic stress disorder. An independent advisory panel of experts will review the studies on Tuesday and is expected to vote on whether the treatment would be effective and whether its benefits outweigh the risks.
The panel will hear from Lykos Therapeutics, which has presented clinical trial evidence in an effort to gain agency approval to legally sell the drug to treat people with a combination of MDMA and psychotherapy.
Millions of Americans suffer from PTSD, including military veterans who are at high risk of suicide. No new treatment has been approved for PTSD in more than 20 years.
What is MDMA?
Methylenedioxymethamphetamine (MDMA) is a synthetic psychoactive drug first developed by Merck in 1912. After being resynthesized in the mid-1970s by Alexander Shulgin, a Bay Area psychedelic chemist, MDMA gained popularity among therapists. . Early research suggested significant therapeutic potential for a number of mental health conditions.
MDMA is an entactogen or empathogen that promotes self-awareness, feelings of empathy, and social connection. It is not a classic psychedelic like LSD or psilocybin, drugs that can cause altered realities and hallucinations. Among recreational users, MDMA is commonly known as molly or ecstasy.
In 1985, when the drug became a staple at dance clubs and raves, the Drug Enforcement Administration (DEA) classified MDMA as a Schedule I substance, a drug defined as having no accepted medical use and having a high potential of abuse.
Are there health risks?
FDA staff expressed concern about “significant increases” in blood pressure and pulse rate among some participants in Lykos clinical trials, noting that these were risks that could “trigger cardiovascular events.”
Many experts in the field say that the drug is generally safe and non-addictive in its pure form.
Adverse reactions associated with MDMA when taken outside of a clinical setting are often caused by adulterants such as methamphetamine and synthetic cathinones, often known as bath salts.
Some recreational users report lower mood in the days after taking MDMA, most likely due to a temporary shortage of serotonin in the brain, but experts say more research is needed.
What is the approval framework?
In 2017, the FDA granted “breakthrough” status to MDMA-assisted therapy. The status, a recognition of a drug’s therapeutic promise, is intended to shorten the regulatory timeline.
The original application was sponsored by the nonprofit Multidisciplinary Association for Psychedelic Studies, which earlier this year created a for-profit entity, Lykos Therapeutics, to market MDMA if it wins FDA approval.
The application presents an unusual challenge for the FDA, which typically does not regulate drug treatments that are combined with psychotherapy, an essential part of Lykos’ regimen for treating post-traumatic stress disorder.
On June 4, an expert advisory panel will review Lykos’ clinical data, along with public comments and a staff analysis, to make recommendations to the FDA. The agency often follows the panel’s suggestions and a final decision is expected in mid-August.
What do therapy sessions entail?
About 200 patients in Lykos clinical trials underwent three sessions, each lasting eight hours, in which about half received MDMA and half received a placebo, according to a report published in Nature Medicine. The sessions were separated by four weeks.
The patients also had three appointments to prepare for therapy and nine more in which they discussed what they had learned.
The most recent drug trial found that more than 86 percent of those given MDMA achieved a measurable reduction in the severity of their symptoms. About 71 percent of the participants improved enough to no longer meet the criteria for a PTSD diagnosis.
Any approval by the agency would likely be restricted. The drug was studied during sessions assisted by a psychotherapist and, for safety, by a second therapist, given the vulnerability of the patients. The FDA staff analysis proposed some limits on the drug’s approval, including that it be given only in certain settings, that patients be monitored and that adverse effects be tracked.
But doctors and therapists could still prescribe MDMA without authorization, expanding its potential for treating other illnesses such as depression or anxiety.
What are the chances of the FDA approving it?
Although the two studies supporting Lykos’ request suggest that MDMA therapy produced significant improvements in patients with post-traumatic stress disorder, an FDA staff report released last week highlighted shortcomings in the study designs. In particular, the report highlighted the high percentage of participants who were able to determine whether they had been administered MDMA or a placebo, a phenomenon common to many drug trials involving psychoactive compounds.
The Institute for Clinical and Economic Review, a nonprofit that examines drug costs and effectiveness, criticized the studies and described the results as “inconclusive.”
Overall, the FDA’s analysis was largely positive, noting that participants “experienced a statistically and clinically significant improvement in their PTSD symptoms, and that improvement appears to be lasting for at least several months.”
Are there other uses for MDMA?
There are a number of ongoing studies exploring MDMA’s potential to treat a wide range of difficult-to-treat mental health problems, including obsessive-compulsive disorder and major depression.
Dr. Joshua Gordon, director of the National Institute of Mental Health, said early data on MDMA and other psychedelic compounds has electrified the field of psychiatry, especially research suggesting they can produce lasting benefits after just a handful of treatments.
But he warned against hoping too much. “MDMA therapy has the potential to be at least as effective as other agents we have, and the effects can last for a while,” she said. “But it’s not going to work for everyone. “It’s not a miracle drug.”