This site is updated Hourly Every Day

Trending Featured Popular Today, Right Now

Colorado's Only Reliable Source for Daily News @ Marijuana, Psychedelics & more...

Post: The FDA Just Rejected a Bid for MDMA to Treat PTSD

Picture of Anschutz Medical Campus

Anschutz Medical Campus

AnschutzMedicalCampus.com is an independent website not associated or affiliated with CU Anschutz Medical Campus, CU, or Fitzsimons innovation campus.

Recent Posts

Anschutz Medical Campus

The FDA Just Rejected a Bid for MDMA to Treat PTSD
Facebook
X
LinkedIn
WhatsApp
Telegram
Threads
Email

Photograph: Ward DeWitt; Getty Listen to this story The US Food and Drug Administration has rejected a first-of-its-kind proposal to use the psychedelic drug MDMA , also known as ecstasy or Molly, as a treatment for post-traumatic stress disorder.

Drugmaker Lykos Therapeutics had asked the FDA to approve the drug in combination with talk therapy. The company said Friday that the regulatory agency has requested an additional Phase 3 trial so that the safety and efficacy of the therapy can be further studied. The decision comes after an FDA advisory panel in June concluded that there wasn’t enough evidence to recommend its approval.

Lykos said it plans to request a meeting with the FDA to ask for reconsideration of the decision and to further discuss the agency’s recommendations. "The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades," said Lykos CEO Amy Emerson in a company statement . She added that conducting another Phase 3 trial would take several years.

As many as 13 million Americans suffer from PTSD in any given year, according to the National Center for PTSD. Just two drugs have been specifically approved to treat the disorder, with the latest being greenlit by the FDA in 2000. The lack of options has turned combat veterans into unlikely advocates for MDMA-assisted therapy. In the days leading up to the FDA decision, veterans groups and members of Congress from both parties pressed for its approval.

In a letter to President Biden , more than 300 veterans and representatives of veterans service organizations wrote that MDMA-assisted therapy “offers desperately needed hope for veterans and their families, with the potential to save and drastically improve countless lives over the coming years.”

A bipartisan group of more than 60 members of the House of Representatives and 19 senators also voiced their support for the therapy this week. “Given the substantial burden of PTSD and the current treatment […]

Leave a Reply

Your email address will not be published. Required fields are marked *

You Might Be Interested...