The active ingredient that makes magic mushrooms so magic—the psychedelic drug psilocybin—is one step closer to becoming a legal treatment for difficult cases of depression. This week, the company Compass Pathways announced that it had received the Food and Drug Administration’s Breakthrough Therapy designation for its psilocybin-based treatment. The designation will fast track the FDA’s review of the treatment for possible approval.
While many people who have recreationally taken psilocybin and other mind-altering drugs can attest to the positive feelings they leave behind, research into these drugs’ possible mental health benefits has been stifled for decades. Psilocybin and other psychedelics, such as LSD and DMT, are federally classified as Schedule I controlled substances in the U.S., meaning they aren’t considered to have any accepted medical use. By contrast, the opioids used as prescription painkillers are Schedule II drugs, meaning they’re recognized as medically helpful, but have a high potential for abuse.
But in recent years, doctors, patients, and even pharmaceutical companies have slowly begun to convince the government to reconsider its stance, aided by small pilot studies showing that these drugs, usually in “microdoses” smaller than a person would take recreationally, can help treat depression, anxiety, and even drug addiction. That’s partially what makes the breakthrough designation so important, since it’s also a recognition by the FDA that a potential drug has some “preliminary clinical evidence” for its claimed effects—effects that might trump those of any other existing treatment available.
In the case of psilocybin, studies in the UK and U.S. have found that it could treat people with depression who haven’t responded well to other treatments. And Compass is set to fund the first large-scale trial of psilocybin that will run in North America and Europe over the next year, according to the company (Compass’ version of psilocybin comes in a powder form, synthesized in the lab). The drug’s development is the first major project for the UK-based company, founded in 2016.
“This is great news for patients. We are excited to be taking this work forward with our clinical trial on psilocybin therapy for treatment-resistant depression,” said George Goldsmith, the executive chairman of Compass, in a statement. “The FDA will be working closely with us to expedite the development process and increase the chances of getting this treatment to people suffering with depression as quickly as possible.”
The announcement is only the latest bit of good news for the field of psychedelic medicine.
A nasal spray version of ketamine, which is a veterinary anesthetic and club drug, could soon be approved by the FDA for treatment-resistant depression, following mixed but overall positive results reported in Phase 3 clinical trials. The nasal spray version, called esketamine and being developed by Johnson & Johnson, received a breakthrough designation in 2016. And last year, the FDA also granted breakthrough status to a research program that uses MDMA (a component of the party drugs molly and ecstasy) in combination with psychotherapy to treat post-traumatic stress disorder. The program was developed and is undergoing its own Phase 3 clinical trials with the help of the non-profit organization Multidisciplinary Association for Psychedelic Studies (MAPS).
“Like the FDA’s granting of Breakthrough Therapy designation for MAPS’ MDMA-assisted psychotherapy for PTSD research program last year, this news further legitimizes the field of psychedelic medicine,” Brad Burge, director of Strategic Communications at MAPS, told Gizmodo via email. “The pair of Breakthrough Therapy designations send a clear message that psychedelic therapy is likely to be the next major paradigm shift in psychiatry.”