Psilocybin For Anorexia Gets FDA Study Approval

Xpira Pharmaceuticals is one step closer to commercializing a treatment for anorexia that uses psilocybin.

A privately-owned Canadian pharmaceutical company is one step closer to commercializing a treatment for anorexia that uses psilocybin.

Xpira Pharmaceuticals will initiate a Phase 2a clinical trial looking at the efficacy of psilocybin-assisted therapeutic protocols in patients suffering from anorexia after receiving approval from the U.S. Food and Drug Administration for its first Investigational New Drug application.

The Toronto-based firm said it aims to contribute to the successful outcome of treatment for patients with anorexia, including enhancing patients’ quality of life by furthering the development of its psilocybin-assisted treatment.

“With clear clinical endpoints and a robust study design, and taking into full account the vulnerability of (anorexia) patients, we hope to move closer to a treatment that will both improve the prognosis of sufferers and bring us closer to a more complete understanding of this pervasive and difficult to treat condition,” said Xpira’s VP of Clinical Development Allan Kaplan.

Anorexia nervosa is one of the deadliest mental illnesses known to psychiatric medicine, the company said, for which there is currently no approved treatment regimen — neither pharmacologic nor psychotherapeutic.

This critical regulatory approval from the FDA “reinforces Xpira’s commitment towards improved clinical outcomes for patients suffering from eating disorders,” the release said.

Xpira also said it has worked to ensure a safe and effective trial design “to provide a higher standard of care for patients while providing value for its shareholders.”

With this trial progressing, the company “has moved to establish a clear differentiation for itself through its clinical expertise and pursuit of specific indications in both the growing market for psychedelic therapeutics and the landscape of pharmaceutical companies committed to the development of treatments for eating disorders.”

Kaplan, who has researched eating disorders for 35 years, is also a senior clinician at the Center for Addiction and Mental Health in Toronto, as well as a professor in the Department of Psychiatry at the University of Toronto’s Temerty Faculty of Medicine. He has lectured widely on various topics in the field; having published 200 peer-reviewed articles, two books, 60 book chapters and over 200 abstracts.

“Throughout my career as a psychiatrist, I have participated in many high-profile pharmacological trials in (anorexia), all of which failed to meet their objectives,” said Kaplan.

“Because of what we now know of its neurobiology, and the mechanism of action of psilocybin on brain circuitry, I believe that (anorexia) could be potentially successfully treated with psilocybin, when utilized and overseen properly within the parameters of psychedelic-assisted psychotherapy.”

Kaplan has also led both the Academy for Eating Disorders, the largest organization of eating disorder professionals in the world, and the International Eating Disorder Research Society.

Adam Jackson

Adam Jackson covers the cannabis industry for The Green Market Report. He previously covered the Missouri statehouse for The Columbia Missourian and freelanced for The Missouri Independent. He most recently covered retail, restaurants, and other consumer companies for Bloomberg Business News. You can find him on Twitter @adam_sjackson and email him at adam.jackson@crain.com.


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