MDMA approval for post-traumatic stress disorder could come in 2024

A man shows an MDMA tablet. Photo by Ennio Leanza/EPA-EFE

NEW YORK, Nov. 17 (UPI) -- The Food and Drug Administration soon may approve the recreational psychedelic drug MDMA -- alongside supportive therapy -- to treat post-traumatic stress disorder after two late-stage studies found it effective.

MDMA, sometimes called Molly or Ecstasy, has gained attention from use at dance clubs, music festivals and parties, and in couples counseling. Users say it increases energy and emotional warmth, as well as distorted sensory and time perception, according to the National Institute on Drug Abuse.

"The FDA has not approved a drug to treat PTSD in more than two decades. It is currently reviewing data from these studies, and many in the field are optimistically hoping for MDMA to be approved," Dr. Mashal Khan, an expert in addiction psychiatry at Weill Cornell Medicine in New York, told UPI via email.

He added that "this brings a lot of hope for treatment providers and patients alike, and I imagine, especially for those who struggle with PTSD symptoms resistant to traditional therapies."

A study published last month in Nature Medicine found that MDMA used in conjunction with psychotherapy "reduced PTSD symptoms and functional impairment in a diverse population with moderate to severe PTSD and was generally well tolerated."

Another large, well-designed, controlled study published in the journal Nature Medicine in 2021 showed significant benefit of MDMA's use for PTSD.

"Post-traumatic stress disorder presents a major public health problem for which currently available treatments are modestly effective," the study's authors wrote.

Dr. Christopher Pittenger, a professor of psychiatry at Yale University School of Medicine in New Haven, Conn., who was not involved in the study, told UPI via email that adjunct psychotherapy still is essential.

"Importantly, MDMA treatment in these [PTSD] studies is embedded in an extensive program of psychotherapy before, during and after drug dosing," Pittenger said. "This is not a case of drug treatment standing on its own."

Other studies have explored MDMA's therapeutic effect in treating depression, anxiety, social anxiety in autism, psychological distress related to life-threatening illnesses, relationship therapy, and alcohol and substance use disorders.

MDMA works by fostering feelings of closeness and connection with others, prompting researchers to investigate its value as a complement to traditional talk therapy.

"So far, some studies found modest improvements in symptoms," University of Chicago researchers Hanna Molla and Harriet de Wit told UPI in an email.

Molla is a postdoctoral fellow in the department of psychiatry and behavioral neuroscience, where de Wit is a professor.

They recently published a study in Scientific Reports that closely examined the pharmacological effects of MDMA and its impact on social interactions.

In carefully controlled experiments, they found that volunteers who took MDMA reported feeling significantly more connected when talking with strangers, compared to conversation partners with whom they interacted after taking a placebo.

"Part of [MDMA's] therapeutic potential is thought to be due to its ability to enhance the bond between the therapist and the patient," Molla and de Wit said.

They found that MDMA boosts the presence of oxytocin, a social bonding hormone, and that the feelings of connection are associated with this increase.

MDMA facilitates empathy and openness and decreases defensiveness, but it also induces neuroplasticity -- the ability of neurons to rewire and strengthen connections, said Ronald Cowan, professor and chair of the department of psychiatry at the University of Tennessee Health Science Center in Memphis.

"I think that both therapist-to-patient connection and neuroplasticity are factors in treatment of PTSD and other conditions," Cowan said.

The website lists 26 studies in progress or pending enrollment for MDMA and psychotherapy. "These are not the same as FDA applications for new drug approval," Cowan said, "but [they] point to the range of interest and the various sponsors."

Due to "a moral panic over recreational use," the U.S. Drug Enforcement Administration placed MDMA into its highest risk category, defined as "no accepted medical use and high potential for abuse," psychiatrist Franklin King told UPI via email.

The agency's decision "was contested by many psychiatrists and therapists, who testified at that time to MDMA's immensely beneficial effects in psychotherapy," said King, director of training and education at the Center for Neuroscience of Psychedelics at Massachusetts General Hospital.

In response to the government's action, the Multidisciplinary Association for Psychedelic Studies, an advocacy group, was formed in 1986, leading efforts to obtain the government's permission to conduct research on MDMA.

MAPS Public Benefit Corp., of San Jose, Calif., which is overseeing the process, told UPI via email that more than 1,900 people have received MDMA in clinical trials. It anticipates filing a new drug application with the FDA before the end of this year.

If investigational MDMA-assisted therapy is approved by the FDA, MAPS Public Benefit Corp. will contract with a manufacturer to produce the drug.

It "has been pursuing FDA approval for MDMA-assisted therapy for [PTSD] for decades, and it's expected that this may happen in 2024," King said. That extended length of time "being on the precipice of FDA approval," he added, is "unprecedented in the world of drug development."