MDMA Therapy Moves Closer to FDA Approval

MDMA therapy for treating moderate to severe post-traumatic stress disorder is one step closer to being approved by the FDA after a study found it effectively reduces symptoms.

Mounting evidence suggests that psychedelic drug 3,4-methylenedioxymethamphetamine (MDMA), also known as ecstasy or molly, may be beneficial in treating mental disorders.

Australia has already approved MDMA therapy for the treatment of post-traumatic stress disorder (PTSD) earlier this year. The findings of the recent study published in Nature Medicine suggest it could also soon happen in the United States.

The second, confirmatory Phase 3 trial included 104 participants with PTSD who had lived with the condition for 16 years on average. Most of them (73.1%) had a severe form of PTSD. Among them were veterans, survivors of sexual assault, and victims of childhood trauma.

Unlike the first Phase 3 trial, the new study enrolled a more diverse population — 35 of 104 participants were non-White, and 28 were Hispanic/Latino.

The participants were randomized into two groups: receiving MDMA or placebo, accompanied by 90-minute talk therapy sessions.

MDMA-assisted therapy significantly reduced PTSD symptoms compared to placebo and therapy. By the end of the study, 71.2% of participants in the MDMA-assisted therapy group no longer met the criteria for PTSD diagnosis, compared to 47.6% in the placebo group.

Additionally, 46.2% of participants in the MDMA group and 21.4% of participants in the placebo group met remission criteria.

The study confirmed the results of the first Phase 3 clinical trial published in 2021 that involved 90 people receiving either MDMA or placebo. After two months, 67% of participants in the MDMA therapy group no longer qualified for a PTSD diagnosis, compared with 32% in the placebo and therapy group.

The studies were sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) and administered by MAPS Public Benefit Corporation (MAPS PBC), a subsidiary of MAPS. MAPS PBC is now compiling data from their trials to form the basis of the New Drug Application, expected to be filed with the FDA later this year.

"We hope that MDMA-assisted therapy for PTSD will be approved by the FDA next year — and that our Open Science, Open Books principle will inspire researchers to make this just the first of many psychedelic-assisted therapies to be validated through diligent research."

- Rick Doblin, PhD, MAPS Founder and President

In 1985, the U.S. Drug Enforcement Administration (DEA) listed MDMA as a Schedule I drug, meaning it had “no currently accepted medical use and a high potential for abuse.” However, based on previous MAPS-sponsored trials, the FDA has designated MDMA as a “breakthrough therapy” in 2017.

In June, the FDA approved using LaNeo, an MDMA investigational medical product developed by PharmAla Biotech, in clinical trials for treating schizophrenia.

What is PTSD?

PTSD is a serious neuropsychiatric condition affecting about 5% of Americans each year. It develops in some people who have experienced a shocking or dangerous event, such as combat, physical or sexual assault, abuse, or an accident, among others.

People with PTSD often suffer from co-occurring conditions, including depression, substance use, and anxiety disorder.

PTSD symptoms usually begin within three months of the traumatic event:

• Re-experiencing symptoms can include flashbacks of the traumatic event, memories or dreams related to the event, as well as physical signs of stress.
• Staying away from places or events that remind of the traumatic experience or avoiding thoughts about them are considered avoidance symptoms.
• Arousal and reactivity symptoms include feeling tense, on guard, or on edge, having difficulty sleeping, having angry or aggressive outbursts, and engaging in risky or destructive behavior.
• Ongoing negative emotions, such as fear, anger, guilt, or shame, loss of interest in enjoyable activities, and social isolation are examples of cognition and mood symptoms.

MDMA therapy shows promise in treating moderate to severe PTSD. However, whether the FDA will grant the approval and how the drug will be regulated is yet to be seen.