The federal advisory committee has voted against MDMA use, commonly known as ecstasy, as a treatment for post-traumatic stress disorder (PTSD). The independent committee, which included experts from various fields, expressed significant concerns about the integrity and design of the trials presented by Lykos Therapeutics, the treatment's sponsor.
The committee's vote followed presentations from the FDA, Lykos Therapeutics, and public testimonies. Out of 11 committee members, only two believed the treatment was effective, and just one thought the benefits were greater than the risks. The remaining members cited various issues, including bias in efficacy data and incomplete safety information.
MDMA, a psychoactive drug known for producing feelings of emotional transparency and connection, is currently classified as a Schedule I drug under the Controlled Substances Act, indicating no accepted medical use and a high potential for abuse. The FDA has final authority on whether to approve the treatment but often follows the recommendations of its advisory committees.
Lykos Therapeutics presented data from two late-stage clinical trials involving about 200 participants who underwent three eight-hour MDMA-assisted therapy sessions. Despite some committee members acknowledging the potential of this novel treatment, concerns about bias and safety data persisted. The studies were designed to be double-blind, but many participants could identify if they received MDMA due to its hallucinogenic effects, undermining the trial’s objectivity.
The Institute for Clinical and Economic Review, a nonprofit that reviews treatments, also expressed doubts about the validity of the trial results, pointing to potential bias from unblinding and other influences. Safety concerns were also raised, including MDMA’s known risks to heart and liver health. The FDA noted significant increases in blood pressure and pulse among participants, with some related assessments incomplete.
Panel member Dr. Paul Holtzheimer, deputy director for research at the National Center for PTSD, voted against the treatment, highlighting the need for new PTSD treatments but cautioning against premature approval that might hinder further development. Dr. Walter Dunn, the only committee member to vote in favor, acknowledged the potential risks but emphasized the urgent need for effective PTSD treatments, especially for veterans.
I absolutely agree that we need new and better treatments for PTSD, especially in the somatic treatment space. However, I also note that premature introduction of a treatment can actually stifle development and stifle implementation and lead to premature adoption of treatments that are either not completely known to be safe not fully effective or not being used at their optimal efficacy.Dr. Paul Holtzheimer, deputy director for research at the National Center for PTSD
The FDA's decision, expected by mid-August, will be closely watched as it could set a precedent for the approval of psychedelic drugs for medical use. The committee's reservations also included concerns about therapist bias and misconduct during the trials. Allegations of patient abuse and undue influence on patient reports were discussed, although the FDA confirmed ongoing inspections and asked the committee not to consider these unverified claims in their vote.
Public testimonies included personal accounts from PTSD sufferers who experienced significant improvements with MDMA-assisted therapy, urging the FDA to approve the treatment. However, experts stressed the importance of rigorous regulations and ongoing monitoring to ensure patient safety if the drug is approved.
(Input from various sources)
(Rehash/ Susmita Bhandary/MSM)