The evidence failed to show the benefits outweighing the risks.
An advisory panel of the U.S. Food and Drug Administration (FDA) voted against recommending MDMA, a psychedelic drug, for the treatment of post-traumatic stress disorder (PTSD) on Tuesday.
The panel voted 10-1, determining that the evidence presented so far did not demonstrate that the benefits of MDMA outweigh its risks, as reported by the Associated Press.
During the meeting, panel members highlighted concerns about flawed study data and significant risks associated with the drug, including potential heart problems, injury, and abuse.
Dr. Melissa Decker Barone, a psychologist with the Department of Veterans Affairs, expressed skepticism about the effectiveness of the treatment due to various issues with the data presented, according to the AP.
The FDA is expected to make a final decision by August, with the panel’s vote potentially influencing the agency’s decision-making process, as reported by the AP.
MDMA is the first of several psychedelics, including LSD and psilocybin, slated for FDA review in the coming years, the AP noted.
However, FDA advisers cited concerns about flawed studies, including missing follow-up data on patient outcomes and a lack of diversity among participants. Most patients involved in the studies were white, with only a small number of Black patients receiving MDMA, according to the AP.
In response to the panel’s decision, Lykos Therapeutics, the company developing the MDMA treatment, expressed disappointment but pledged to address the panel’s concerns in collaboration with regulators.
The difficulty of determining the extent to which patients’ improvement was due to MDMA versus extensive therapy, as well as issues with patients being able to guess whether they received MDMA or a placebo, further complicated the evaluation process, the AP reported.
Dr. Rajesh Narendran, a psychiatrist from the University of Pittsburgh who chaired the panel, expressed skepticism about the drug’s effectiveness based on the data presented.
Despite the panel’s decision, several experts encouraged continued research into psychedelics for PTSD treatment, emphasizing the potential benefits while also urging caution regarding safety and efficacy, the AP reported.
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