Life sciences company COMPASS Pathways has been awarded Breakthrough Therapy Designation from the US Food and Drugs Administration (FDA) for psilocybin therapy – its new method for tackling treatment-resistant depression.
COMPASS says that the designation is a significant milestone for psilocybin therapy and psilocybin research. Originally funded by The Heffner Research Institute, early studies were conducted at Johns Hopkins University, New York University, and Harbor-UCLA, and further research was undertaken in 2015 at Imperial College London.
“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,” said George Goldsmith, Executive Chairman, COMPASS Pathways. “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.”
COMPASS has started the first large-scale psilocybin therapy clinical trial in Europe and Northern America. There are thought to be around 100 million people worldwide with depression that do not respond to existing treatments and COMPASS asserts it is one of the fastest growing health problems we face today.
“The Breakthrough Therapy designation for psilocybin therapy highlights the importance of supporting early research that can be translated to clinically meaningful outcomes,” said Dr Robin Carhart-Harris, Head of the Psychedelic Research Group, Imperial College London.