FDA grants breakthrough therapy designation to psilocybin therapy for treatment-resistant depression

The FDA granted Compass Pathways a Breakthrough Therapy designation for its psilocybin therapy for treatment-resistant depression, according to a press release.

The Breakthrough Therapy designation for psilocybin therapy emphasized the importance of supporting early research that can be translated to clinically meaningful outcomes for patients with treatment-resistant depression, the release stated.

Based on years of research in the U.S., the U.K. and Switzerland, the designation marks a significant milestone for psilocybin therapy, according to the release. In the U.K., researchers conducted a proof-of-concept study of psilocybin for treatment-resistant depression at in 2015, finding that psilocybin plus psychological support showed promising efficacy and safety results, according to the release. Compass Pathways will be running the first large-scale psilocybin therapy clinical trial for treatment-resistant depression in Europe and North America over the next year, the release said.

"This is great news for patients. We are excited to be taking this work forward with our clinical trial on psilocybin therapy for treatment-resistant depression,” George Goldsmith, executive chairman of Compass Pathways, said in the release. “The FDA will be working closely with us to expedite the development process and increase the chances of getting this treatment to people suffering with depression as quickly as possible."

Disclosure: Goldsmith is executive chairman of Compass Pathways.