FDA Gives Psilocybin Clinical Studies Breakthrough Therapy Status

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:



Is Psychedelic Tourism Destroying the Sanctity of Plant Medicine?

As psychedelic healing and plant medicine go more mainstream, luxury psychedelic tourism is on the rise—good news for the spread of this medicine, but how might over-commercialism affect this sacred practice?

A recent Bloomberg article highlights the rise in all-inclusive psychedelic retreats. Indigenous plant medicine has been around for centuries, and its health benefits have been scientifically demonstrated, but as it gains mainstream acceptance and finds a bigger audience, some only see dollar signs.

Bloomberg reports, “according to Data Bridge Market Research the psychedelic market is expected to grow from $3.8 billion in 2020 to $10.7 billion by 2027.”

With the potential to make a lot of money, could some unscrupulous companies capitalize on this trend and remove the sanctity of this practice?

Carlos Tanner is the director of The Ayahuasca Foundation in Peru, he founded the center in 2009 as the result of his own healing journey. “When I started our retreat center, The Ayahuasca Foundation, I was coming off of a seven-year study myself; a four-year apprenticeship where I lived with a curandero and several years after that of studying with other teachers,” Tanner said.

“For most people that were starting centers at that time—which wasn’t many—you were a student first, and eventually after years of study, you came to the point where you wanted to offer this to people from outside of the culture. Now we see people who don’t have very much experience at all, but yet they’re opening a healing center.”

As this budding industry is dealing with rapid growth, there are some complicated issues regarding its increased popularity.

“When it comes to the commercialization of substances that have an ancestral background I would say that it is a delicate situation, and I hope that there would be a benefit to those indigenous populations from which those traditions were orignated. But at the same time, I know many indigenous people and they are for the spreading of what they believe to be their culture, which oftentimes was something that was looked upon negatively or was degraded as if they were second-class citizens, quite literally,” Tanner said.

“But now having people from the Western world, from the modern world, want to learn or experience elements of their culture, I think gives them a sense of pride. So it’s a complex question, to say the least.”

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