The Future of MDMA, Psilocybin, and Psychedelics in the US
memany were surprised when, on February 3, Australian regulators announced that drugs containing the psychedelic substances MDMA and psilocybin may soon be used to treat post-traumatic stress disorder (PTSD) and depression treatment resistance, respectively. That decision makes Australia the first country in the world to formally recognize the therapeutic use of psychedelics.
Other countries, including the US, may be headed for a similar outcome, some experts say.
Research is increasingly showing that psychedelics can be powerful tools for treating a variety of mental health conditions, from PTSD and depression to addiction and eating disorders. “I’ve been doing this for 11 years,” says Albert Perez Garcia-Romeu, an assistant professor of psychiatric and behavioral sciences at the Johns Hopkins University School of Medicine who studies psychedelics. “Most of the people I’ve worked with in this process have been helped by their experiences, and the data is very consistent. “
In November 2022, the US non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) announced that it had completed a second phase three trial of MDMA as a treatment for PTSD – a step widely seen as the final hurdle to clear before applying for approval from the US Food and Drug Administration (FDA). Although the data from that study has not yet been published in a peer-reviewed journal, MAPS says its findings echo positive results from its first phase three MDMA trial, which was published in the journal. Natural medicine in 2021, who found that PTSD patients who took MDMA while also receiving treatment reported significant improvements in their symptoms 18 weeks after their first dose, compared to those who received a placebo. Rick Doblin, founder and executive director of MAPS, says his organization is preparing to apply for FDA approval based on that data. If all goes well, he says, the drug could be approved as soon as 2024.
Research on psilocybin, the psychoactive component in “magic” mushrooms, may take a little longer to progress to that point, Garcia-Romeu says, but he expects psilocybin to be considered for FDA approval within a few years. In November 2022, results from a phase two psilocybin trial were published in the New England Journal of Medicine. They found that a single 25-milligram dose of psilocybin reduced symptoms among people with treatment-resistant depression over three weeks, although it came with side effects including headache, nausea , and dizziness.
The Australian approval of these drugs, Doblin said, may not stimulate the approval process in the US but “It’s going to help regulators in the US and elsewhere feel more comfortable,” he said. rulers like to be the first or the only ones.”
A representative for the FDA did not respond to TIME’s request for comment by press time. But in a May 2022 letter first published by the Intercept, an official from the US Department of Health and Human Services wrote that FDA approval for MDMA and psilocybin was “anticipated” within “approximately 24 months.”
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The FDA has also given MDMA and psilocybin “breakthrough therapy” status. That designation recognizes the therapeutic potential of a drug and is intended to streamline the road from research to approval. The agency has also allowed a small number of people to use MDMA under what it calls “expanded access,” a program aimed at helping severely ill patients who have not responded to other treatments to drugs that are still being used. to help study.
Regulators in other countries have made similar decisions. Switzerland, Canada, and Israel allow clinicians to use certain psychedelics in special circumstances for patients with severe conditions. Jamaica and Costa Rica, among other countries, also operate legal psilocybin clinics.
Some US states have also legalized the use of psychedelics. The use of psilocybin became legal in Oregon on January 1 when it was used by adults under the supervision of a licensed facilitator, and Colorado residents recently voted to do the same. Legislation to legalize psilocybin has been introduced in states including Connecticut, New Jersey, and California.
Australia, however, is the first country in the world to provide psychedelics for medicinal use at a national level, starting on July 1. Despite their decision to give MDMA and psilocybin to patients, Australian regulators have not approved any medication containing these substances. To prescribe drugs that are still technically unapproved, psychiatrists must apply to become authorized prescribers – a process that involves obtaining approval from Australia’s Therapeutic Goods Administration (TGA) and an ethics committee human research, and obtaining permission to import the drugs from the Australian Office. of drug control.
That’s a “departure” from the normal process, says Dr. Michael Bogenschutz, director of the NYU Langone Center for Psychedelic Medicine. “Allowing [a drug] to be used as if it had already been approved is a concern to me.”
While Bogenshutz is excited by the advances in psychedelics research, and says it’s “looking more and more like these drugs might find their place in medicine,” he worries about passion that surpasses science. “We hope [psychedelics] that will be a real breakthrough, but we can’t say that’s true until we’ve collected and analyzed the evidence needed to make that decision,” he said.
TGA Australia admitted in its February 3 announcement that “there is little evidence that the substances are beneficial in treating mental illness,” but added that “access to new treatments is needed for treatment-resistant conditions.”
Doblin says his concern about Australia’s plan is whether licensed psychologists will receive adequate training. “The drug is not the treatment,” he says. “The drug makes the treatment more effective, but it’s about the treatment. MAPS leadership has recommended to US regulators that therapists complete a 100-hour training program before they can use MDMA to treat patients.
That warning is primarily to ensure that patients receive the best care, but also to help the distribution of drugs go as smoothly as possible.
“Things that happen in one country are really broadcast around the world,” Doblin says. That means that anything that happens in Australia, for better or worse, could have a major impact on countries around the world.
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