Psilocybin: The FDA grants the status of "revolutionary therapy" to magic mushrooms

TThe US Food and Drug Administration has given a group of psychiatrists the blessing of dosing magic mushrooms to patients during therapy sessions. This week, the FDA granted "disruptive therapy" status to COMPASS Pathways' psilocybin-assisted therapy for treatment-refractory depression. The London-based life sciences company, supported in part by Peter Thiel, will use the psychedelic drug psilocybin, the active ingredient extracted from psychedelic mushrooms, to treat patients in Europe and North America as part of a new program. a phase 2b trial to determine the optimal dose of the drug.

For scientists studying psychedelic drugs, the FDA initiative is good news. The Breakthrough Therapy designation, created in 2012, allows the FDA to closely assist researchers in the development of a promising drug for the treatment of serious illnesses or conditions.

Roland Griffiths, Ph.D., professor of psychiatry and behavioral science at Johns Hopkins University, leads the laboratory that conducted the first approved, approved, FDA-approved psilocybin clinical trial in 2000. He is encouraged by this news.

"This is a significant positive development in the potential future approval of psilocybin, a classic psychedelic drug, for medicinal purposes," said Griffiths. reverse. "After decades of research on psilocybin and related psychedelic drugs, researchers in the United States and Europe have demonstrated the safety and preliminary signs of efficacy of psilocybin in various therapeutic applications."

Kelan Thomas, Pharm.D., Associate Professor of Clinical Sciences at the University of Touro, California, co-authored a Journal of Psychoactive Drugs review of psilocybin-assisted therapy in 2017, in which he and his team predicted the role of the compound in the future of psychiatry.

"I was very surprised that the FDA had already granted the disruptive therapy designation, only two months after having approved the design of the study," Thomas said. reverse. "Usually, the FDA wants to evaluate data from Phase 2b trials of the drug's sponsor before granting the disruptive therapy designation, but perhaps the data from previous clinical trials on psilocybin, summarized in my 2017 article. , were sufficient evidence. "

But Griffiths explains that the designation "Revolutionary Therapy" does not necessarily indicate that the FDA will approve the widespread use of psilocybin. This means that the FDA considers psilocybin-assisted therapy as a new approach to the specific treatment of refractory depression, a condition that affects up to 50% of patients with clinical depression.

Matthew Johnson, Ph.D., an associate professor of psychiatry and behavioral science at Hopkins, who works with Griffiths on psilocybin research, acknowledges this news is important.

"The breakthrough status of the FDA is a big problem," he says reverse. "This implies that the FDA recognizes that treatment is potentially one that would have a significant impact on a largely under-treated condition. It also means that the FDA is working more closely with the sponsor given the potential benefits to public health and goes beyond the typical "just facts, ma'am" relationship that it typically has with a pharmaceutical sponsor. "

This means that instead of just reviewing COMPASS clinical trial results, the FDA will make constructive recommendations more quickly than it would with conventional drug trials.

The FDA would not issue any comment on the news, citing the confidential status of disruptive therapy applications. But COMPASS Pathways announced the development itself on Tuesday.

For Johnson and Griffiths, the news suggests that the FDA has become more willing to look at psilocybin from the point of view of science and public health, rather than taking the position of fear or misunderstanding. This change was slow, as the psychedelic heyday of the 1960s sparked a culture of fear around psychedelic drugs, meaning that scientists in general could not touch them for decades.

"We do not have a scientific field – except perhaps chemical weapons or the war against germs – where there is a cultural consensus that it is so dangerous that we should not do anything with them," explains Griffiths. But because of the work done over the last 18 years at Johns Hopkins University, Imperial College London, New York University and other academic institutions around the world, this cultural consensus is change and the FDA's decision is proof of that. Johnson says breakthrough therapy designation says FDA will not be "warned against [psilocybin] for political and non-scientific reasons ".

"I think it's a big step forward to get those compounds out of the dark era and make them potentially culturally acceptable to systematically explore other applications," Griffiths says.

All of this becomes possible because scientists have acquired enough basic knowledge of psilocybin to be able to confidently pursue human trials, knowing that they are unlikely to do serious harm to volunteers.

In the newspaper, Griffiths, Johnson and their colleagues have published a lengthy analysis of the potential of psilocybin to harm people. neuropharmacology. In the paper, they conclude that psilocybin has a very low potential for abuse and dependence, and a low potential to harm those who take it.

They also recommended transferring psilocybin to Schedule IV of the Controlled Substances Act, category including drugs such as Xanax and Ambien. At present, the drug is designated in Schedule I – with heroin – which means that it has no medicinal value and that it's not a drug. it is likely to harm people. But as research accumulates, the law will have to catch up.

Griffiths would like to point out that psilocybin is not always harmless. In a 2016 survey in the Journal of Psychopharmacology, the Hopkins team found that out of 1,993 people who had a difficult psychedelic experience ("bad trips"), 7.6% of them ended up seeking professional treatment for their psychological symptoms, which persisted long after the disappearance of drugs.

"Although the addiction According to Griffiths, the liability for these drugs is low, which does not mean that they are safe and that they must certainly be regulated in one way or another. The FDA will ultimately be responsible for determining the parameters of this regulation. "

It remains to be seen whether it looks like a central pharmacy dispensing drugs directly to psychiatrists, or maybe something else, but Griffiths is rather sure of one thing: