According to the company COMPASS Pathways, which specializes in drugs for the treatment of mental health, the chemical psilocybin derived from the fungus Psilocybe semilanceata, is promising in terms of treatment-resistant depression. Most patients with depression are prescribed serotonin reuptake inhibitors. However, these are not effective in all cases.
COMPASS is involved with developing therapies that involve neuroscience, psychotherapy, psychopharmacology and medical technology.
PharmaPhorum notes that the U.S. Food and Drug Administration (FDA) is massing evidence about the drug and will soon be determining whether a drug based on psilocybin can aid the treatment of depression. In relation to the work of COMPASS, the FDA has designated the potential antidepressant as a ‘Breakthrough Therapy’ and has given the go-ahead for experiments involving people to take place.
Various studies are on-going in relation to psilocybin, including studies from the U.S., U.K. and Switzerland. In the U.S. this includes the Heffter Research Institute, Johns Hopkins University, New York University, and Harbor-UCLA Medical Center. In the U.K., the Medical Research Council has sponsored a proof-of-concept study.
COMPASS is conducting its own study – a clinical trial for treatment-resistant depression. This will take place in both the U.S. and Europe in 2019. If successful, a antidepressant based on psilocybin could be suitable for FDA fast-tracking, where experimental results are reviewed quickly and the process for getting a drug to the market can be accelerated.
In a statement, George Goldsmith, chairman, COMPASS Pathways, notes: “We are excited to be taking this work forward with our clinical trial on psilocybin therapy for treatment-resistant depression.”
The main obstacle is that psilocybin is deemed a “schedule 1” drug in the U.S. Psilocybin is a psychedelic prodrug compound produced by more than 200 species of mushrooms, although some species like P. semilanceata are more potent than others.
In the human body, psilocybin is rapidly converted to psilocin and this triggers mind-altering effects such as euphoria, visual and mental hallucinations, differences in perception, a loss of a sense of time, and adverse reactions like panic attacks or vomiting.
