Evergreen Youth Secrets
  • Health News
  • Health Care
  • Staying Healthy
  • Beauty Advices
  • Health News
  • Health Care
  • Staying Healthy
  • Beauty Advices
No Result
View All Result
Evergreen Youth Secrets
No Result
View All Result
Home Health Care

FDA panel rejects MDMA-based treatment for PTSD

by
June 5, 2024
in Health Care
0
FDA panel rejects MDMA-based treatment for PTSD

A potential treatment for post-traumatic stress disorder using the psychedelic MDMA was overwhelmingly rejected by a panel of federal regulators on Tuesday, marking what could be a major setback for the use of psychedelics in the treatment of mental illness.

The Food and Drug Administration (FDA) panel voted 10-1 against endorsing the safety of MDMA in treating PTSD, and 9-2 against its efficacy. The group cited flawed studies, unclear data and potential for damaging side effects.

The FDA is not required to follow the panel’s recommendation in whether to approve the use of MDMA, though the thorough criticism could be used as a rationale to reject the treatment.

“It seems like there are so many problems with the data — each one alone might be OK, but when you pile them on top of each other … there’s just a lot of questions I would have about how effective the treatment is,” said panel member Dr. Melissa Decker Barone, a psychologist with the Department of Veterans Affairs.

Tuesday’s panel meeting was the first time it ever considered the use of a Schedule 1 psychedelic drug for medical use. The MDMA treatment could be the first new treatment for PTSD in decades.

Lykos Therapeutics, the company behind the treatment, is backed by the country’s leading psychedelic advocacy group, the Multidisciplinary Association for Psychedelic Studies. It said in a statement that it will work with the FDA to achieve approval in the future.

“We are disappointed in today’s vote given the urgent unmet need in PTSD and appreciate that the committee faced a challenging and atypical assignment, which was to evaluate a therapeutic approach that combines drug therapy (MDMA) and psychological intervention,” CEO Amy Emerson wrote. 

The FDA panel specifically noted concerns about the diversity of the studies’ subjects and the replicability of its results. The panel noted that because MDMA is a psychedelic, patients could easily determine if they were given a placebo dose, making the study “blinding” impossible. 

The drug’s psychedelic nature also made its specific impacts harder to track due to the general difficult-to-describe nature of the drug. MDMA does not cause hallucinations as with other psychedelics but rather changes a person’s emotions. 

MDMA treatment advocacy group Healing Breakthroughs thoroughly criticized the panel’s vote, saying regulators had “missed the forest for the trees.”

“Six thousand veterans have died from suicide every single year since 9/11,” Juliana Mercer, the group’s veteran advocacy director, said in a statement. “This is a gut-wrenching statistic that has remained unchanged, despite billions of taxpayer dollars and myriad treatments that have proven ineffective in bringing the veteran suicide epidemic to an end.”

The Lykos study, which the panel criticized, found that the MDMA treatment had about 71 percent efficacy for PTSD.

“Delaying FDA approval of MDMA-AT dashes the hopes of millions of Americans who suffer

from PTSD,” Healing Breakthrough warned in a statement. “It also means that more veteran lives will be unnecessarily lost to suicide this year, and every year, until this therapy is approved.”

The FDA is expected to issue its final decision on the treatment by Aug. 11.

Previous Post

Federal judge rules North Carolina residents can take abortion drug at home

Next Post

More older Americans worried about Medicare future: Survey

Next Post
More older Americans worried about Medicare future: Survey

More older Americans worried about Medicare future: Survey

Stay updated with the latest news, exclusive offers, and special promotions. Sign up now and be the first to know! As a member, you'll receive curated content, insider tips, and invitations to exclusive events. Don't miss out on being part of something special.

    Popular News

    Spanberger hits Earle-Sears over health care, education in new ad

    Spanberger hits Earle-Sears over health care, education in new ad

    September 22, 2025
    Trump administration halts government hunger report

    Trump administration halts government hunger report

    September 22, 2025
    Former acting CDC director says he ‘can’t look to’ center for trusted info 

    Former acting CDC director says he ‘can’t look to’ center for trusted info 

    September 21, 2025

    Trending

    Suicide among female doctors gets a closer look

    Suicide among female doctors gets a closer look

    October 9, 2024
    22 states sue to block Trump cuts to NIH research payments

    22 states sue to block Trump cuts to NIH research payments

    February 10, 2025
    Fall River fire fuels calls for federal assisted living legislation  

    Fall River fire fuels calls for federal assisted living legislation  

    July 17, 2025
    White House withdraws CDC director nomination

    White House withdraws CDC director nomination

    March 14, 2025

    Recent News

    Spanberger hits Earle-Sears over health care, education in new ad

    Spanberger hits Earle-Sears over health care, education in new ad

    September 22, 2025
    Trump administration halts government hunger report

    Trump administration halts government hunger report

    September 22, 2025

    Popular News

    • Spanberger hits Earle-Sears over health care, education in new ad
    • Trump administration halts government hunger report

    About Evergreen Youth Secrets

    • Contact us
    • Privacy Policy
    • Terms & Conditions
    • Email Whitelisting

    Copyright © 2025 Evergreenyouthsecrets.com. All Rights Reserved.

    No Result
    View All Result
    • Health News
    • Health Care
    • Staying Healthy
    • Beauty Advices

    Copyright © 2025 Evergreenyouthsecrets.com. All Rights Reserved.