IOn February 3, Australian regulators announced Drugs containing the psychedelic substances MDMA and psilocybin are readily available to treat post-traumatic stress disorder (PTSD) and treatment-resistant depression, respectively. become the first country in the world to recognize
Some experts say other countries, including the United States, may be headed for a similar outcome.
Research increasingly suggests that psychedelics can be a powerful tool for treating a range 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 psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine who studies hallucinogens. “The vast majority of people I’ve worked with in this process have been helped by their experience, and the data is amazingly consistent.”
In November 2022, the US nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) announced that Second Phase 3 Study Completed This step is widely seen as the final hurdle before submitting to the U.S. Food and Drug Administration (FDA) for approval. Data from that study have not yet been published in a peer-reviewed journal, but MAPS To tell The findings reflect the positive results of First Phase 3 MDMA Trialpublished in magazines natural medicine In 2021, it was found that PTSD patients who took MDMA while receiving treatment reported significant improvement in symptoms 18 weeks after their first dose compared to those who received placebo. Executive director Rick Doblin said his group is preparing to apply for FDA approval based on these data. If all goes well, the drug could be approved as early as 2024, he says.
Research into psilocybin, the psychoactive ingredient in “magic” mushrooms, may take a little longer to get to that stage, says Garcia Romeu, but psilocybin is considering FDA approval in the next few years. Phase 2 psilocybin trial results in November 2022 published in the New England Journal of Medicine. They found that a single dose of 25 milligrams of psilocybin relieved symptoms over three weeks in people with treatment-resistant depression, although it had side effects such as headache, nausea and dizziness.
Doblin said Australia’s approval of these drugs may only speed up the approval process in the United States. “Regulators don’t like to be the first or the only one.”
An FDA representative did not respond to TIME’s request for comment by press time.However, in a letter of May 2022 first published According to The Intercept, a U.S. Department of Health and Human Services official wrote that FDA approval of MDMA and psilocybin is “expected” within “about 24 months.”
read more: Inside Ibogaine, one of the most promising and dangerous psychedelics for addiction
The FDA also previously granted MDMA and psilocybin “breakthrough therapy” status. This designation is intended to recognize the therapeutic potential of the drug and to streamline the path from research to approval.The agency also allowed a limited number of people to use MDMA under what is known asExpanding accessis a program aimed at helping critically ill patients who have not responded to other treatments try drugs that are still being studied.
Regulators in other countries have made similar decisions. Switzerland, Canadaand Israel Allows clinicians to use certain psychedelics under certain circumstances for critically ill patients. Jamaica and Costa Rica, among other countries, already operate legal psilocybin clinics.
Some states in the United States have also accepted the use of psychedelics. Psilocybin legalized in Oregon on January 1 Colorado residents recently voted to do the same when used by adults under the supervision of a licensed facilitator. in states such as Connecticut, New Jersey, and California.
However, Australia will be the first country in the world to allow psychedelics for medical use nationwide from 1 July. Australian regulators have not approved medicines containing MDMA and psilocybin, despite their decision to make them available to patients. To prescribe drugs that are technically not yet approved, psychiatrists must apply to become licensed prescribers. This process involves obtaining approval from both the Australian Therapeutic Goods Administration (TGA) and the Human Research Ethics Committee and permission to import the drug from our Australian office. of drug management.
This is a “deviation” from the standard process, says Dr. Michael Bogenshutz, director of the Langone Center for Psychedelic Medicine at New York University. “To give permission [a drug] It’s something I’m concerned about being used as if it’s already approved. “
Bogenshutz is excited about advances in psychedelic research, stating that “it looks more and more likely that these drugs will find a place in medicine,” but that enthusiasm outweighs science. I am concerned about [psychedelics] It would be a big breakthrough, but until we accumulate and analyze the evidence necessary to make that decision, we can’t say it’s true,” he says.
Australia’s TGA, in a February 3 announcement, acknowledged that “there is limited evidence that substances are beneficial in the treatment of psychiatric disorders”, but that “access to new treatments for treatment-resistant conditions is is necessary,” he argued.
Doblin says his concern with the Australian plan is whether licensed psychiatrists receive proper training. “Medicines make treatment more effective, but that’s the problem with treatment.” MAPS leadership ensures therapists complete a 100-hour training program before using his MDMA to treat patients. Recommended by US regulators.
That attention is primarily to ensure that the patient receives the best possible care, but also to ensure that the drug rollout proceeds as smoothly as possible.
“What happens in one country is actually broadcast all over the world,” says Doblin. So whatever happens in Australia can have ripple effects in countries around the world, for better or worse.
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