August 13, 2024
Nik Shuliahin/UNSPLASH.COM
The FDA declined to approve MDMA as a treatment for post-traumatic stress disorder.
The Food and Drug Administration's decision to not approve a therapy using MDMA – also known as ecstasy and molly – to treat post-traumatic stress disorder means momentum for the use of psychedelics in behavioral health may now come from the state level, an expert said.
"The FDA decision was deeply disappointing to everyone who cares about making what is an exciting breakthrough treatment available to the people who can benefit from it," said Taylor West, executive director of the Healing Advocacy Fund, a nonprofit that promotes the safe use of psychedelic therapy. "And at the same time, I think it is a real signal that the path to providing these therapies to people who need them is going to run through the states, that a federal bureaucracy is clearly not set up to evaluate this kind of combination of medicine plus therapy that is inextricable from one another."
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Lykos Therapeutics's research into MDMA-assisted psychotherapy offered hope to approximately 13 million Americans who have PTSD, which often occurs after people witness a traumatic event or experience a series of traumas. It can cause crippling mental health issues and lead people to suicide. The only medications approved for treating PTSD are the selective serotonin reuptake inhibitors Paxil and Zoloft, often used in combination with various forms of cognitive behavioral therapy and exposure therapy. Last year, Lykos published data from a clinical trial showing that 86% of more than 100 people who had PTSD for an average of 15 years found relief through MDMA-assisted therapy and that more than 70% of people in the study went into complete remission.
But an independent advisory panel recommended in June that the FDA reject approval of MDMA-assisted therapy, citing concerns about the drug's safety, lack of diversity in the study group and the integrity of the research. For instance, because of MDMA's known hallucinogenic effects, people in the control group most likely knew they were not receiving the drug. On Friday, the FDA told Lykos that it could not approve its use of MDMA "based on data submitted to date" and called for another major study, which could cost millions of dollars and several more years.
The leaders of the Multidisciplinary Association for Psychedelic Studies – which shares ownership of Lykos with "mission-aligned investors" – responded in a statement that it would ask the FDA to reconsider its decision and that Lykos would "work diligently in the coming months to address the FDA's concerns." But momentum for the use of psychedelics in mental health treatment is most likely now to move from the states to the federal level, West said.
"The call to action from this FDA process is that states are going to be the home for innovation around these treatments," West said. "... We are seeing some precedent for the success of state-level programs ultimately influencing change at the federal level."
Part of the problem that Lykos ran into is that federal regulators are used to approving medications in and of themselves, not as part of an overall treatment protocol that involves therapy, West said.
The model Lykos has been studying calls for PTSD patients to have several standard psychotherapy sessions before their first treatment with the drug, which is administered in a six-to-eight-hour session that's monitored by a pair of therapists. More standard psychotherapy sessions follow to help patients integrate what arose for them during the session with the drug.
"You are using this medicine to enhance the therapy, make it more effective, and that clearly was not something that the FDA was able to evaluate, but that is why the state model is our hope for progress right now," West said.
In addition to the MDMA studies, researchers have for years been investigating the possible therapeutic effects of psilocybin, a chemical found in certain mushrooms that can produce hallucinogenic effects. Studies have shown that psilocybin, also known as magic mushrooms and shrooms, may be helpful in treating substance use disorders, as well as depression and anxiety. Psilocybin has also shown to be effective at easing anxiety and depression in people with cancer and helping them reach a sense of acceptance of their illness.
Oregon voters approved the first psilocybin therapy program in 2020, which ultimately launched last year. Approximately 5,000 Oregonians have now received psilocybin-assisted treatment in the presence of trained professionals for their depression, anxiety and/or substance use disorders. Colorado voters also approved a ballot initiative in 2022 to allow supervised psychedelic-assisted therapy at licensed healing centers under the care of trained, licensed facilitators.
The Drug Enforcement Administration designates psilocybin a Schedule I substance, meaning it has a high potential for abuse, no known medical use and a lack of accepted safety for use in medical treatment, but the federal government has not interfered with its implementation into mental health protocols in Oregon or Colorado.
"The research throughout the field is substantial enough and impressive enough that a setback at the federal level does not raise concerns about the effectiveness of these therapies," West said. "We believe in them and believe people deserve access to them."
