The US Food and Drug Administration has made the decision to grant "Breakthrough Therapy" status for psychedelic mushrooms. The fungus, most commonly used as a recreational drug, is now being considered as a therapy for depression that isn't responding to other pharmaceutical treatment. Breakthrough Therapy status is only granted by the FDA when enough research has been done to demonstrate the potential of the new drug.
The groundbreaking treatment is the brainchild of Compass Pathways, a company that focuses its mission statement on widening the available options to patients with mental health issues. Dr. Robin Carhart-Harris of Imperial College London undertook a study in 2015 on the mushrooms, giving them to 19 patients alongside a course of therapy. The results showed a substantial improvement in mood.
Around 100 million people in the world suffer from depression that isn't helped by prescription medications or other leading treatments, making this an exciting new development in the field. Researchers have also extensively tested the drug on animals, including rats who responded to the drug in a promising way. Some members of the medical community have voiced concerns that using psychedelic mushrooms could lead to dependency, but rats didn't continuously press the lever for more when given access like they do when tested with heroin, alcohol or cocaine.
Despite this, researchers have strongly suggested that should the treatment be rolled out, it should be administered in a clinical environment only, under tightly monitored circumstances. It is highly unlikely that there will ever be a scenario in which doctors will hand over a prescription for patients to collect themselves, but they would be able to attend an appointment in a specialized practice and have the psilocybin given to them in a similar way to how an anesthesiologist prescribes and administers. This way, the effects could be measured and safety ensured.
Chairman of Compass Pathways, George Goldsmith, says that patients should be elated at the news, and looks forward to working closely with the FDA to try and officially roll out the breakthrough.