The Food and Drug Administration (FDA) is considering whether to approve the use of MDMA, also known as Ecstasy, to treat post-traumatic stress disorder. An independent expert advisory panel is expected to review the study on Tuesday and vote on whether the treatment is effective and whether its benefits outweigh the risks.
The panel will hear from Lykos Therapeutics, which submitted evidence from a clinical trial as part of an effort to win agency approval to legally sell the drug to treat people who use MDMA and talk therapy together.
Millions of Americans suffer from PTSD, including veterans who are at high risk for suicide. No new treatments for PTSD have been approved in the past 20 years.
What is MDMA?
Methylenedioxymethamphetamine (MDMA) is a synthetic psychoactive drug first developed by Merck in 1912. After being resynthesized by Bay Area psychedelic chemist Alexander Shulgin in the mid-1970s, MDMA gained popularity among therapists. Early research suggests significant therapeutic potential for a variety of mental health conditions.
MDMA is an interactive or empathogen that promotes self-awareness, empathy, and social connectedness. This is not a classic hallucinogenic drug like LSD or psilocybin, which can alter reality and cause hallucinations. Among recreational users, MDMA is commonly known as molly or ecstasy.
In 1985, as the drug became a staple in dance clubs and raves, the Drug Enforcement Administration classified MDMA as a Schedule I substance, defined as medically unacceptable and with a high potential for abuse.
Are there any health risks?
Agency staff at the FDA raised concerns about “significant increases” in blood pressure and pulse rate in some participants in the Lykos clinical trial, noting that this “may pose a risk of cardiovascular events.”
Many experts in the field say that the drug is generally safe and non-addictive in its pure form.
Side effects associated with MDMA when taken outside of a clinical setting are often caused by impurities such as methamphetamine and synthetic cathinones, known as bath salts.
Some recreational users report feeling worse for a few days after taking MDMA, which is likely due to a temporary lack of serotonin in the brain, but experts say more research is needed.
What is the framework for approval?
In 2017, the FDA granted “breakthrough” status to MDMA-assisted therapy. This status, which recognizes the drug's therapeutic potential, aims to accelerate regulatory timelines.
The original application was sponsored by the nonprofit Multidisciplinary Association for Psychedelic Studies, which earlier this year formed a for-profit entity, Lykos Therapeutics, to sell MDMA once it receives FDA approval.
The application presents an unusual challenge for the FDA, which does not typically regulate drug treatments combined with talk therapy, which is an integral part of Lykos' regimen for the treatment of PTSD.
On June 4, an expert advisory group is reviewing Lykos' clinical data, along with public comments and staff analysis, to make recommendations to the FDA. The FDA often follows the panel's suggestions, and a final decision is expected in mid-August.
What does a therapy session include?
According to a report published in Nature Medicine, about 200 patients in the Lykos clinical trial underwent three sessions of eight hours each, with about half given MDMA and the other half given a placebo. Sessions were held four weeks apart.
Patients also had three appointments to prepare for treatment and nine more to discuss what they had learned.
The most recent drug trial found that more than 86% of people who took MDMA experienced a measurable reduction in the severity of their symptoms. Approximately 71% of participants improved to the point where they no longer met diagnostic criteria for PTSD.
Agency approval will probably be limited. The drug was studied during sessions attended by a psychotherapist and, for safety reasons and taking into account the patient's vulnerability, a second therapist. The FDA staff analysis suggested several restrictions on approving the drug, including administering it only in certain settings, monitoring patients, and tracking side effects.
However, doctors and therapists may still prescribe MDMA off-label, expanding its potential to treat other conditions, such as depression or anxiety.
What are the chances of FDA approval?
Two studies supporting Lykos' application found that MDMA treatment led to significant improvements in PTSD patients, but an FDA staff report released last week highlighted shortcomings in the study design. Most notably, the report noted a high proportion of participants who were able to determine whether they had received MDMA or a placebo, a phenomenon common in many drug trials involving psychoactive compounds.
The Institute for Clinical and Economic Review, a nonprofit group that examines the costs and effectiveness of drugs, criticized the study and described the results as “inconclusive.”
Overall, the FDA analysis was largely positive, noting that participants “experienced statistically significant and clinically meaningful improvements in PTSD symptoms, and the improvements appear to last for at least several months.”
Can MDMA be used for other purposes?
Much research continues to explore MDMA's potential to treat a wide range of difficult-to-treat mental health conditions, 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 have excited the field of psychiatry, particularly that they may produce lasting benefits even after several treatments. Mentioned research results suggesting that
But he warned against having too much hope. “MDMA therapy is likely to be at least as effective as other drugs we have, and its effects may last for some time,” he said. “But it doesn’t work for everyone. “It’s not a miracle drug.”