For the first time in U.S. history, a psychedelic drug is on the fast track to getting approved for treating depression by the federal government. Late last month, Compass Pathways, a U.K.-based company that researches and develops mental health treatments, announced the FDA granted them what’s called a “breakthrough therapy designation” for their trials into psilocybin, the psychoactive ingredient in psychedelic mushrooms.
Researchers who pioneered psychedelic science agree — this is a landmark moment for their field.
“It really does represent a significant development in the whole history of psychedelic research,” says University of California, Los Angeles psychiatry and behavioral sciences professor Charles Grob, who conducted foundational psilocybin trials at UCLA in the mid-2000s.
To Grob and others, the FDA’s recognition of psilocybin isn’t just about psilocybin; It indicates a larger shift in how the federal government perceives psychedelic drugs. Researchers only began receiving approval to investigate psychedelics in the 90s, after they were banned from science for decades due to their association with Woodstock-era iconoclasts.
In August 2017, the FDA gave its first indication that times were changing when it granted MDMA — often confused with ecstasy — a breakthrough therapy designation for post-traumatic stress disorder. Researchers now see both the success of MDMA and psilocybin as a sign that “the psychedelic renaissance,” the resurgence of psychedelic drug research, is finally helping psychedelic medicine receive the recognition it deserves.
Rick Doblin, founder of the Multidisciplinary Association of Psychedelic Studies (MAPS) and a psychedelic research pioneer, predicts that MDMA and psilocybin could now both be legal by 2021. They wouldn’t be legalized for prescription, but, rather, legalized to be administered by therapists who have been trained in what’s called “psychedelic-assisted psychotherapy.” In the case of psilocybin, a therapist or therapy team meets with the patient prior to their trip to psychologically prepare them; monitors them throughout their trip (typically eight hours or so); and then helps them process their experience afterwards.
If Compass is successful, psilocybin will be approved by the FDA for patients with treatment-resistant depression, or patients who have not responded to traditional anti-depressants. Part of the reason Compass received a breakthrough therapy designation is because there’s a dire need for novel depression treatments in the U.S.
Psilocybin has already proven effective as a mental health treatment in cancer patients suffering from end-of-life distress. Johns Hopkins University, New York University, and UCLA have all conducted trials which have consistently found that a significant number of patients saw their depression and anxiety decrease, if not fully go away, while ranking their trips among the most meaningful experiences of their lives, alongside events like the birth of a first child.
The data from these trials, among others, was used by Compass to receive FDA approval. Researchers are careful to point out, however, that these trials, conducted in cancer patients with end-of-life distress, have limited application for treatment-resistant depression among the general population. There’s only been one promising trial, conducted at the Imperial College London in 2015, looking specifically at treatment-resistant depression — but that only looked at 12 people.
Compass is determined to change that — quickly — and they’re already having unprecedented success in the psychedelic field. They aim to enroll 216 participants in their next round of trials. They have research sites in the United Kingdom and the Netherlands, with the intention of getting psilocybin approved for prescription in Europe, too. Notably, they’re also backed by billionaires including Peter Thiel and ex-hedge fund manager Michael Novogratz, an indication to some researchers in the field that psychedelics have gone mainstream.
There’s only one other organization in the U.S. that’s close to developing a classic psychedelic — MDMA is not considered one of them — into a treatment: a research nonprofit called the Usona Institute. They, too, have received FDA approval for their psilocybin trials in the hopes of getting psilocybin approved for anyone with depression, not just those who are treatment-resistant. Doblin says Compass getting breakthrough therapy designation status should help Usona, or anyone else who wants, get it too.
There’s consensus among the psychedelic community that Compass’ success with the FDA will make it easier for everyone else in the field to get approved for research. If Compass continues to succeed and gets psilocybin approved for depression, Doblin predicts it will be eligible for “off label” prescription, in which doctors will be able to prescribe it for any condition they see fit. That means all the psilocybin research conducted for academic purposes could be used to prescribe psilocybin for conditions like addiction to cigarettes or alcohol.
For the last decade or so, psychedelic pioneers have trodden lightly, concerned that at any moment they might once again lose the freedom to conduct their life’s work. But now, it appears they’ve come too far to go back — and the federal government is finally recognizing it, too.
Correction: A previous version of this article called the company Compass Therapeutics; They now go by the name Compass Pathways.