FDA Gives Psilocybin Clinical Studies Breakthrough Therapy Status
The FDA recognized psilocybin, the psychoactive compound in magic mushrooms, with “Breakthrough Therapy” designation for clinical trials studying its use for treatment-resistant depression by a company called Compass Pathways. The group plans to treat patients in Europe and North America over the next year in placebo-controlled studies to determine proper dosage and treatment methods.
Since hallucinogenic drugs were given Schedule I designation in 1966, psilocin and psilocybin have been villainized by the media and politicians who claim it has a high potential for abuse and no medical application. But recent studies from esteemed research institutions, including Johns Hopkins and London’s Imperial College, have helped ease misconceptions and stigma surrounding the drug, and now government regulatory bodies are seeing its potential.
Compass Pathways, a life sciences company founded in 2016 whose focus is to “accelerate patient access to evidence-based innovation in mental health,” specifically through research with psilocybin, was given the go-ahead by the FDA back in August, but the recent designation was an unexpected acknowledgment, according to some of those involved in its research.
According to the FDA, “Breakthrough Therapy” means it reviewed the findings of researchers it granted use of the drug to and viewed their results as:
“Preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.”
Once this designation is given, the FDA expedites the development and review of the drug, hopefully allowing medical professionals to soon begin implementing it as a legal, viable treatment and eventually change the scheduling of the drug.
Dr. Roland Griffiths, one of the foremost researchers in government-sanctioned studies of hallucinogenic drugs, told Inverse he’s hopeful the regulatory approval will change, though he doesn’t envision it becoming available from a pharmacy anytime soon, if ever.
Griffiths and his colleagues have mostly advocated for its use in controlled settings with guided sessions from a trained psychologist. He’s also stated he believes it can be a dangerous drug when taken by those with certain pre-existing mental illnesses, notably schizophrenia.
But now that studies have shown psilocybin to act as a “reset mechanism” in the brain for those suffering from severe forms of depression, this latest recognition from the FDA may allow psilocybin treatment to become available for those desperately needing it. This breakthrough may also pave the way for FDA trials with other psychedelic substances, such as LSD, currently studied by Griffiths and others in his field.
For more on Dr. Roland Griffith’s and other cutting edge work studying clinical treatments with psychedelic substances, check out this episode of Psychedelica:
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Strongest Psychedelic Known to Man Now Being Used in Clinical Trials
The world’s first regulated clinical trial of DMT clears the way for Earth’s most powerful psychoactive drug to join the psychedelic therapy revolution.
DMT, or N, N-Dimethyltryptamine, is a highly potent hallucinogen that naturally occurs in many plant species, including in one of the plant ingredients of ayahuasca. It can also be synthetically produced in a laboratory.
DMT is known for inducing intense metaphysical trips, which are reportedly similar to near-death experiences. Having been used underground in the west for decades, it is now attracting the interest of pharmaceutical companies and scientists looking to investigate its potential mental health benefits.
Jay Waxenberg is the director of the DMTx program at the Center for Medicinal Mindfulness. Based in Boulder, CO, it was one of the first centers to offer legal psychedelic therapy in the U.S.
“DMT is actually the most powerful psychedelic on Earth that we’re aware of, and what makes it special and different from other psychedelics is that it’s endogenous, which means it’s produced within our own bodies. It’s also produced in nearly every ecosystem on Earth — it’s everywhere, it’s all around us – which is also kind of leading to what is really unique about it, the extent of a DMT experience, it’s at most 20 minutes,” Waxenberg said.
While there is a wide range of phenomena experienced during a DMT trip, there are some fascinating common hallmarks.
“This alternate reality experience, or this experience that people will call ‘realer than real.’ It’s a reality similar to our own, but completely different,” Waxenberg said. “Some of the elements within that would be the entity encounters, which is very common for people; intense geometric, hyperbolic shapes; and out-of-body, traveling to the center of the universe; ego-dissolution, ego death; these are really common experiences under it.”
While advocates have been reporting profound healing benefits for decades, there have not been any clinical studies on DMT due to its status as a Schedule 1 controlled substance, until now.
