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An FDA panel just rejected using MDMA to treat PTSD. Here are 5 things to know about the psychedelic drug.

MDMA is an illegal drug that can enhance a person's sense of well-being and empathy toward other people.
MDMA is an illegal drug that can enhance a person's sense of well-being and empathy toward other people. (Getty Images)

An independent panel for the Food and Drug Administration (FDA) has rejected the use of MDMA as a form of therapy for posttraumatic stress disorder (PTSD). MDMA, which is also known as ecstasy, is seen by some in the scientific community as a potential breakthrough treatment for PTSD, a mental health condition that’s difficult to treat effectively.

The panel overwhelmingly voted against the treatment, with the committee voting 9 to 2 that the human trials of MDMA for PTSD did not prove it was an effective therapy. The panel also voted 10 to 1 that the risks of using MDMA for PTSD outweigh the benefits. Worth noting: While FDA officials don’t need to follow the advice of the panel, the organization often does. The FDA review is part of a larger look into the potential use of psychedelic drugs for conditions that are typically difficult to treat, including depression and addiction.

Before the vote on MDMA took place, some members of the panel said they were concerned about the design of two studies submitted by Lykos Therapeutics, which makes the drug. A big concern was that study participants were usually able to correctly guess whether they had been given MDMA or not. There were also concerns over potential cardiovascular effects of taking the drug and even bias from therapists who led the sessions.

But psychiatrists say there is a lot of encouraging data around using MDMA for PTSD. Here are five key takeaways of this treatment.

Methylenedioxymethamphetamine — which is also known as MDMA, ecstasy and molly — is an illegal drug listed as a Schedule I substance by the FDA. Schedule I substances have a high abuse potential with no accepted medical use, and medications that are in this class may not be prescribed, dispensed or administered, according to the Drug Enforcement Administration (DEA). If MDMA were to be approved by the FDA for PTSD (or to treat any other condition), it would need to be downgraded to a different schedule.

MDMA can cause effects within 45 minutes or so of taking a dose, according to the National Institute on Drug Abuse (NIDA). Those effects can include having an enhanced sense of well-being, being more outgoing and high-energy, acting emotionally warm, having more empathy toward other people, having enhanced sensory perception and having a willingness to talk about emotionally charged memories, the NIDA says.

The way MDMA works on PTSD patients “is not known,” PTSD researcher Rachel Yehuda, professor of psychiatry and neuroscience of trauma at Mount Sinai, tells Yahoo Life. “It seems to function as a catalyst of psychotherapy and allows patients to open up and not avoid difficult experiences so that they can be examined in therapy,” she says.

Dr. Jonathan E. Alpert, chair of the department of psychiatry and behavioral sciences at Montefiore Medical Center, agrees. “The leading hypothesis has been that MDMA works on the circuits on the brain that process traumatic memories and makes it easier for somebody to engage those past experiences or memories with less fear, arousal and avoidance,” he tells Yahoo Life. “That allows, eventually, for those feelings to have less of a hold on their behavior and ability to function.”

These are not fast therapy sessions. Using MDMA for PTSD has been studied in a specific way. Patients have sessions with therapists in advance of getting the medication so they know what to expect before actually taking the drug, Alpert says.

“Then, there are three occasions where they are administered doses of MDMA and stay with two therapists for about eight hours,” he explains. (MDMA is taken orally, Alpert says.) During that time, the therapists stay with them to help make sure that the patient has a safe experience while under the influence of a psychedelic drug.

“After those three sessions, they have three subsequent therapy sessions that are shorter,” Alpert says. “This is an opportunity to talk about the experiences they had while under the influence of MDMA.”

Overall, Yehuda says that the safety data for taking MDMA is good. “But people can be vulnerable and susceptible under MDMA, so the therapy has to be provided by well-trained, ethical therapists,” she says.

People with certain mental health conditions like schizophrenia, bipolar disorder and substance use disorder were excluded from the trials, Alpert points out. “We think they may become more psychotic or that this may worsen a substance use problem if these patients take MDMA,” he says. “But if someone isn’t properly diagnosed with one of these conditions, they may be exposed and put at risk.”

There also can be cardiac risks. “We know MDMA has an effect on blood pressure and pulse,” Alpert says. “For some people, it may make them more susceptible to abnormal cardiac rhythms and there may be an effect on liver function.” Ultimately, Alpert says that MDMA needs to be studied more.

Clinical trials conducted by Lykos, the maker of MDMA that’s used in therapy, found that patients who underwent the therapy said their mental health was significantly improved. In one trial published in 2023, more than 86% of patients who took MDMA had a notable drop in the severity of their PTSD symptoms. About 71% of the study participants who took MDMA had an improvement of their symptoms that was so great, they no longer met the criteria for a PTSD diagnosis.

That was compared to 69% of people who took a placebo who had a reduction in symptoms. Of those, 48% no longer qualified for a PTSD diagnosis.

“It is a very promising modality and helps people confront their traumatic memories and underlying feelings like shame or guilt,” Yehuda says. Alpert says that MDMA has “shown promise” in studies so far.

About 6% of the U.S. population will have PTSD at some point in their lifetime, according to the National Center for PTSD. “PTSD is fairly prevalent,” Alpert says.

But despite this, experts say that PTSD treatments are lacking. “There has not been a new drug for PTSD in the last 25 years and the current treatments do not provide an adequate level of response for most patients,” Yehuda says.

Current treatments include psychotherapy and medications such as selective serotonin reuptake inhibitors (SSRIs). “Medications like SSRIs can dampen symptoms of PTSD,” Yehuda says. While psychotherapy can be helpful, she points out that “a lot of times, it is painful to revisit memories of trauma in psychotherapy.” As a result, Yehuda says that “many people either avoid the most traumatic parts or drop out.”

With existing treatments, “few people fully get better,” Alpert says. Overall, he says there’s “a great need for effective treatments for PTSD.”

“MDMA has shown promise but, right now, it’s very important that further decisions about MDMA are pursued in the same very rigorous regulatory framework that other new treatments for devastating conditions like PTSD or depression are pursued,” Alpert says.