Skip to main content

FDA Asked to Consider Party Drug MDMA as Treatment for PTSD

Medically reviewed by Carmen Pope, BPharm. Last updated on Dec 13, 2023.

By Robin Foster HealthDay Reporter

WEDNESDAY, Dec. 13, 2023 -- A California company has asked the U.S. Food and Drug Administration to approve MDMA, the active ingredient in party drugs like molly and ecstasy, as a treatment for post-traumatic stress disorder (PTSD).

When announcing the new drug application (NDA) filing on Tuesday, MAPS Public Benefit Corp. noted it has been studying the drug for this use for years. The FDA has 60 days to decide whether whether MDMA will be accepted for review and whether it will be fast-tracked through the approval process, the company said. The drug would be given in concert with talk therapy.

“The filing of our NDA is the culmination of more than 30 years of clinical research, advocacy, collaboration and dedication to bring a potential new option to adults living with PTSD, a patient group that has experienced little innovation in decades,” MAPS CEO Amy Emerson said in a company news release. “If approved, MDMA-assisted therapy would be the first psychedelic-assisted therapy, which we hope will drive additional investment into new research in mental health.”

MDMA belongs to a class of psychoactive drugs that produce experiences of emotional connection, relatedness and emotional openness.

Meanwhile, roughly 13 million Americans suffer from PTSD each year, the company said. The symptoms can be debilitating, and patients can also suffer anxiety, depression and substance use disorder. That doesn't include the economic burden of treating PTSD, which reaches over $200 billion a year.

On top of that, "there are high treatment discontinuation rates... underscoring the urgent need for novel and effective PTSD therapies," the company said.

Back in 2017, the FDA granted MDMA-assisted therapy a breakthrough therapy designation, which speeds the development and review of drugs used to treat a serious condition that early evidence suggests might be a substantial improvement over available therapies.

The MDMA application included data on two studies, with 90 and 104 participants respectively, that showed MDMA significantly reduced symptoms and impairment associated with PTSD when compared with a placebo. MAPS added that it has now completed a total of six late-stage clinical trials testing MDMA for PTSD.

For now, treating PTSD includes antidepressants and some specialized forms of cognitive behavioral therapy, CNN reported.

If the FDA approves MDMA for this purpose, it would need to be rescheduled, MAPS noted, because it is a schedule I drug under the Controlled Substances Act, which the U.S. Drug Enforcement Administration defines as having no accepted medical use.

Sources

  • MAPS Public Benefit Corp., news release, Dec. 12, 2023
  • CNN

Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

© 2024 HealthDay. All rights reserved.

Posted December 2023

Read this next

PTSD Triples Odds for Teeth Grinding, Study Finds

THURSDAY, May 16, 2024 -- People with post-traumatic stress disorder (PTSD) face more than triple the odds of bruxism, otherwise known as teeth grinding, a new study finds. The...

$282 Billion: What Mental Illness Costs America Each Year

WEDNESDAY, April 24, 2024 -- America’s mental health woes essentially serve as an annual economic downturn for the nation, a new study says. Mental illness costs the U.S...

Big Improvements Seen in Spotting, Treating Mental Health Issues Around Pregnancy

TUESDAY, April 2, 2024 -- Expecting or new mothers are much more likely these days to be diagnosed with anxiety, depression and post-traumatic stress disorder, new research...

More news resources

Subscribe to our newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.