Magic mushroom drug could be depression breakthrough, says FDA

Mental health drug specialist COMPASS Pathways said that the FDA has designated the chemical psilocybin, which causes psychoactive effects in those eating magic mushrooms such as Psilocybe semilanceata, as a Breakthrough Therapy in treatment-resistant depression.

The FDA gives the designation to drugs where evidence demonstrates they could be a substantial improvement over available therapies for serious or life-threatening diseases.

Drugs given the designation are hastened through the development process by the FDA, which can grant a faster six-month review if it feels the evidence is still compelling once trials are completed.

The company said in a statement that the designation is a "significant milestone" for psilocybin therapy and psilocybin research, after many years of research by teams in the US, the UK and Switzerland.

The Heffter Research Institute was the first to fund research in this field, and supported early studies at Johns Hopkins University, New York University, and Harbor-UCLA Medical Center.

In the UK, the Medical Research Council backed the proof-of-concept study of psilocybin for treatment-resistant depression at Imperial College London in 2015.

COMPASS is now running the first large-scale psilocybin therapy clinical trial for treatment-resistant depression, which will take place in Europe and North America over the next year or so.

The company said treatment-resistant depression affects approximately 100 million people around the world.

COMPASS is not the only company to research whether drugs based on illegal recreational compounds can be used in mental health: Janssen has developed a nasal spray for treatment resistant depression under review in the US and Europe based on ketamine, illegally used as a party or even a "date rape" drug.

However the FDA’s decision could prove a bureaucratic headache as psilocybin is deemed a highly illegal "schedule 1" drug in the US, with a high potential for abuse and no currently accepted medical use. Psilocybin is also illegal in most European countries.

George Goldsmith, executive chairman, COMPASS Pathways, 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. 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 was found in 2016 to develop mental health therapies based on advances in neuroscience, psychotherapy, psychopharmacology and technology.

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