The use of MDMA as a treatment for post-traumatic stress disorder (PTSD) has been rejected by a U.S. Food and Drug Administration (FDA) committee following recent trials.
The decision was made at an advisory committee meeting on June 4, during which concerns about the treatment's safety and efficacy were raised.
However, this does not mean the discussion is over—and MDMA may yet be coming to U.S. pharmacies.
Ron Shore, a research scientist specializing in psychedelics and assistant professor in the department of psychiatry at Queen's University in Ontario, told Newsweek that while he is not surprised this ruling was rejected, this process is not over.
"As a research scientist I have to agree there are some significant concerns regarding the MDMA trial design, including difficulties in blinding, vague psychotherapeutic protocols, and what may be underreporting of adverse experiences," Shore said.
"On the other hand, as someone who has spent decades working with traumatized populations, including most recently with Canadian military veterans, I know we desperately need new and better therapies for PTSD. Again, this was an advisory committee decision, not the final FDA say on the drug application, so this process will continue and is by no means over."
MDMA, also known as ecstasy, has been studied over a long period of time for its potential to treat PTSD. And recent trials, particularly those conducted by Lykos Therapeutics, showed promising results. The results showed that those who took MDMA in conjunction with psychotherapy were significantly more likely to no longer meet the diagnostic criteria for PTSD compared to those who received a placebo.
However, despite this, there are concerns highlighted in a report from the Institute for Clinical and Economic Review.
One major issue was that researchers were not able to ensure that study participants were unaware of whether they had received the drug or a placebo, meaning results could be biased.
Other issues included that about 40 percent of participants had previously used illicit MDMA, which could have skewed the sample, according to a Nature report.
Additionally, many participants pursued other treatments, including psychedelic drugs, between the initial trial and follow-up, indicating their symptoms might have persisted and their improvement might not have been solely due to MDMA.
Shore said that the FDA has by no means shut the door on psychedelics. Rather, this "has just tempered the contagion and expectancy effects of the research."
"There had been the assumption that legalization was imminent given the successful completion of Phase 3 trials, promising efficacy results, and the previous 'breakthrough therapy' designation. The concerns around psychedelic trial design are well-known in the research community," Shore said.
"This is a complex and novel intervention, quite unlike standard medicine, and MDMA is the first psychedelic compound to get this far in the regulatory approval channel so is the precedent. Everyone is learning along the way and developing the capacity and capabilities to conduct this research [and] understand the issues, and it takes time to prepare clinicians and the public for implementation."
Despite the FDA's rejection, there remains significant interest in the potential of MDMA-assisted therapy for PTSD. Advocates argue that with further refinement, MDMA could still become a valuable treatment option. Lykos Therapeutics plans to continue its research and hopes to address the concerns raised by the FDA in future studies.
"In my opinion, MAPS-Lykos will need to continue the drug development process with a greater emphasis on study design, on clear therapeutic protocols (the psychotherapy side of the treatment), patient safety and risk mitigation," Shore said.
"In the long run, that's probably not a bad idea and will give society and clinicians more time to train and prepare for the unique considerations of these kinds of novel therapies. Ultimately, there is a huge demand in the general public, including significantly among Veterans, for new and better treatments in mental health, so the onus is on us to do the research well and in a timely manner."
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