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About a week ago, an advisory committee to the U.S. Food and Drug Administration (FDA) rejected evidence supporting the approval of MDMA as an alternative treatment for post-traumatic stress disorder (PTSD). This is a deflating moment for many in psychedelic research who have, for years, conducted trials on the drug in an effort to gain approval for commercial distribution.
The application reviewed by the advisory committee was presented by Lykos Therapeutics, which concluded phase 2 and 3 trials investigating the effectiveness of MDMA-assisted therapy in managing post-traumatic stress disorder. In their report, the advisors revealed that they went through the research and cited various missteps and shortcomings on the trials conducted.
This comes as former participants of the trial claimed that adverse events weren’t reported by the company, including suicidality experienced after the treatment. Additionally, there was bias during the trials that may have skewed the findings.
Other issues with the study included the fact that roughly 40% of trial participants had tried MDMA before the study. Additionally, researchers didn’t conduct lab work on MDMA’s safety profile or collect data on each participant’s experience with the drug. In addition, it doesn’t help that a report released after the trials also questioned the data’s validity, which only increased concerns.
The advisory committee also raised concerns about the future of other psychedelics currently being studied for their therapeutic potential. This comes as scientists globally conduct hundreds of trials on these drugs and investors inject billions into research on psychedelics such as LSD, ketamine and psilocybin.
Despite this setback, some are still hopeful that the Food and Drug Administration will approve the treatment in the future. Dr. Srinivas Rao believes that the probability of complete rejection is low. Rao, CEO of atai Life Sciences N.V. (NASDAQ: ATAI), notes that there is a lot of pressure for the drug to get approved. In the event that the drug is approved, Rao posits that the FDA may provide strict requirements and safeguards to conduct additional research once MDMA is on the market.
Matthew Johnson, a senior researcher for the Center of Excellence for Psilocybin Research and Treatment at mental-health provider Sheppard Pratt, believes that even if the drug isn’t approved by the August deadline, MDMA will get approved eventually.
Alan Davis, Ohio State University’s director of the Center for Psychedelic Drug Research and Education, believes that while the rejection is a setback for Lykos Therapeutics, it isn’t for the field as a whole. Davis notes that the main message to gain from the committee’s report is that research will need to be done more thoughtfully now.
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