Psilocybin has been Granted “Breakthrough Therapy” Status by the FDA for Untreatable Depression

The US Food and Drug Administration has granted a group of researchers approval to proceed with the use of the controversial drug psilocybin, a psychedelic compound naturally produced in about 200 species of mushrooms, to treat patients suffering from treatment-resistant depression. This comes as welcome news for researchers that study psychedelic drugs, as current drug laws inhibit the study into the potential medical effects that the forbidden fungus may have to offer.

While there are a variety of treatments for clinical depression, as many as half of the patients suffering from this condition are afflicted with a form that is resistant to standard treatment, but a clinical study conducted at the Imperial College London found that treatments that included doses of psilocybin effectively reset the brains of the patients.

"Several of our patients described feeling ‘reset’ after the treatment and often used computer analogies," according to Robin Carhart-Harris, Ph.D, Imperial College’s Head of Psychedelic Research. "For example, one said he felt like his brain had been ‘defragged’ like a computer hard drive, and another said he felt ‘rebooted’."

Categorized as a Schedule I drug in the US, the legal status of psilocybin falls into the same category as hard street drugs such as DMT, heroin, and marijuana. This new dispensation, granted through the FDA’s "Breakthrough Therapy" designation, allows London-based COMPASS Pathways to proceed with Phase 2b trials in Europe and North America to determine the optimal dosage of the drug for this new treatment. This Breakthrough Therapy designation means that tight controls will still be in place for the drug, with the FDA working with the clinical researchers in developing promising new therapies.

"FDA Breakthrough status is a big deal," explains Matthew Johnson, Ph.D., an associate professor of psychiatry and behavioral sciences at Johns Hopkins University who conducts research into psilocybin. "It implies that the FDA recognizes the treatment is potentially one with a large impact on a largely under-treated condition. It also means that the FDA works more closely with the sponsor given the potential public health benefit, and goes beyond the typical ‘Just the facts, ma’am’ relationship they typically have with a pharmaceutical sponsor."