On Psilocybin, the FDA, Mental Health and More

Photo by Todd DeSantis

• Last week, COMPASS Pathways and King's College London announced the results from their psilocybin study on 89 healthy adult volunteers.

• Dr. James Rucker, from King's College London's Institute of Psychiatry, Psychology and Neuroscience said, “This is the largest controlled study of psilocybin to date. The results of the study are clinically reassuring and support further development of psilocybin as a treatment for patients with mental health problems that haven't improved with conventional therapy, such as treatment-resistant depression.”

• Dr. Ekaterina Malievskaia, Chief Innovation Officer / Co-Founder, COMPASS Pathways said, "This study is part of our overall clinical development programme in treatment-resistant depression … We are focused on getting psilocybin therapy safely to as many patients who would benefit from it as possible."

• Separately, the Usona Institute said they received “Breakthrough Therapy Designation” from the U.S. Food and Drug Administration (FDA) for psilocybin in the treatment of major depressive disorder (MDD).

• In a press release, the organization said, “The designation of psilocybin as a Breakthrough Therapy for MDD acknowledges both the unmet medical need in this broad population and the potential for significant improvements over existing therapies.”

NOTES

• Psilocybin is a naturally occurring hallucinogen produced by over 200 species of mushrooms.

• In addition to treating depression, which affects over 300 million people globally, psilocybin research also focuses on its potential to address headaches, cancer or end-of-life related distress, and addiction with smoke, cocaine or alcohol.  

• The FDA’s Breakthrough Therapy Designation is granted to provide priority review to drug candidates when preliminary clinical trials suggest that a therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases.

• COMPASS Pathways’ “founders are driven by direct and personal experience of treatment-resistant depression, of the inconsistency of health system responses to mental health issues, and of the need for better care options.”

• Usona Institute, based in Madison, WI, “conducts research to further the understanding of the therapeutic effects of psilocybin and other consciousness-expanding medicines.”

OUR TAKE

• Psilocybin and other psychedelic drug research will increase, but the timing of regulatory approval and decriminalization present market uncertainty. The market will likely evolve to address the needs of medical and recreational users.

• While psilocybin naturally occurs in various mushrooms, medical use will increasingly focus on synthetic versions where quality and dosage size can be managed in a consistent fashion. 

• Health care innovation will continue to grow, driven by 1) more holistic / personalized solutions, 2) the use of low-cost delivery platforms (smartphones, sensors, etc.) and 3) access to and analysis of new types of data sets.