Stakeholders blast FDA panel’s rejection of MDMA therapy

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The Big Story 

An advisory committee for the Food and Drug Administration (FDA) voted against recommending MDMA-assisted therapy for PTSD, drawing backlash from lawmakers and advocates. 

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The members of the FDA’s Psychopharmacologic Drugs Advisory Committee voted 9-2 against endorsing the efficacy of MDMA as a treatment for PTSD and 10-1 to reject the question of whether the benefits outweigh the risks. 


The FDA, which designated MDMA-assisted therapy as a “breakthrough therapy” in 2017, is considering an application by Lykos Therapeutics to approve the proposed treatment for PTSD.  


This was the first time the U.S. had considered a Schedule I drug for medical use. A Schedule I designation means a substance has no accepted medical use and a high potential for abuse. 


“I’m disappointed that the FDA advisory committee chose to ignore the voices and testimonies of Veterans whose lives have been forever improved by MDMA-assisted therapy, and instead voted in favor of those who have been on a mission to discredit this promising treatment at all costs,” Rep. Jack Bergman (R-Mich.), a retired lieutenant general in the U.S. Marine Corps, told The Hill. 


“This is a first cure that promises to revolutionize psychiatric treatment in like 50, 60 years, and they’re denying it? Are you kidding me?” Rep. Lou Correa (D-Calif.), who co-chairs the Congressional Psychedelics Advancing Therapies Caucus with Bergman, said in an interview with The Hill. 


While panelists said they were excited by the results, they felt the treatment was still too experimental


“While we are disappointed in the vote, we are committed to continuing to collaborate with the FDA with their ongoing review,” Lykos CEO Amy Emerson said in a statement. “There is an urgent need for new, effective and accessible therapies to address this unmet need for those living with PTSD.” 


Read more here from The Hill’s Taylor Giorno 

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