Psilocybin Trials For Depression Treatment Get Greenlight From FDA

By Victoria Kim 11/01/18
The FDA has recognized the psychedelic compound's therapeutic potential.
Scientists studying psilocybin in a lab.

The U.S. Food and Drug Administration has granted its “Breakthrough Therapy” designation to psilocybin-assisted treatment for depression.

By giving psilocybin research its “Breakthrough Therapy” designation, the FDA is expediting the development and review of psilocybin—the psychedelic compound in “magic mushrooms”—based on the results of preliminary clinical trials that demonstrate its potential to perform better than available treatments.

Previous research on psilocybin has yielded promising results for treating end-of-life anxiety and depression, alcohol and tobacco use disorder and obsessive compulsive disorder.

With the FDA’s blessing, the first large-scale clinical trial for treating refractory (treatment-resistant) depression with psilocybin will run for about one year in Europe and North America.

Psilocybin researchers say this is a significant development in the future of the psychedelic compound’s role in medicine.

“FDA Breakthrough status is a big deal,” Matthew Johnson, PhD, associate professor of psychiatry and behavioral sciences at Johns Hopkins University, told Inverse. “It implies that the FDA recognizes the treatment is potentially one with a large impact on a largely under-treated condition.”

Johnson and his colleagues recommend that the federal government re-categorize psilocybin to Schedule IV, instead of its current place in Schedule I, the category reserved for drugs defined as having a high potential for abuse and no medical value.

In Schedule IV, psilocybin would instead be in the same category as Xanax and Ambien. The scientists say that while there’s less of a risk for harm than heroin (Schedule I), “that doesn’t mean [psilocybin is] safe, and they certainly need to be regulated in some fashion.”

But while the FDA’s Breakthrough designation suggests that psilocybin is closer to mainstream acceptance than ever, it’s unlikely that the potential treatment will be widely distributed to the general population.

Roland Griffiths, PhD, another prominent psilocybin researcher and a colleague of Johnson’s, says, “It seems unlikely that these are compounds that will be dispensed at a pharmacy.”

“This is a significant positive development in the potential future regulatory approval of psilocybin, a classic psychedelic drug, for medicinal purposes,” Griffiths told Inverse.

“After a decades-long hiatus of research with psilocybin and related psychedelic drugs, investigators in the United States and Europe have demonstrated the safety and preliminary signs of efficacy of psilocybin for a variety of therapeutic applications.”

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Victoria is interested in anything that has to do with how mind-altering substances impact society. Find Victoria on LinkedIn or Tumblr