Psilocybin, the hallucinogenic substance found in so-called “magic mushrooms,” is in the process of being “fast tracked” by the FDA to be approved as a treatment for clinical depression.
According to reports, for the second time in a year, the FDA has designated psilocybin therapy — currently being tested in clinical trials — as “breakthrough therapy,” an action that is meant to accelerate the typically sluggish process of drug development and review. A spokesman for the FDA said that granting this kind of acceleration is typically requested by a drug company and “granted only when preliminary evidence suggests the drug may be an enormous improvement over already available therapies.”
According to reporting by Livescience, last year, the FDA granted “breakthrough therapy” status to psilocybin therapy in the still-ongoing clinical trials run by the company Compass Pathways, which are looking into psilocybin’s potential to treat severe treatment-resistant depression or depression in patients who have not improved after undergoing two different antidepressant treatments.
Now, for the second time the status has been granted, this time for a U.S.-based clinical trial conducted by the nonprofit Usona Institute. This clinical trial, which includes 80 participants at seven different sites across the U.S., focuses on the efficacy of treating patients with major depressive disorder (MDD) with a single dose of psilocybin.
There are more than 17 million people in the U.S. who have MDD, or severe depression that lasts more than two weeks, according to a statement from Usona. Psilocybin, with a single dose, could profoundly impact the brain and have long-lasting impacts after wiping away depressive symptoms, according to the company.
The phase 2 trial is expected to be completed by early 2021, and with the help of the “breakthrough status,” Usona expects it to quickly move into a larger phase 3 trial. Around one in three treatments previously given a “breakthrough status,” have moved on to get market approval, reports LiveScience.
“What is truly groundbreaking is FDA’s rightful acknowledgment that MDD, not just the much smaller treatment-resistant depression population, represents an unmet medical need and that the available data suggest that psilocybin may offer a substantial clinical improvement over existing therapies,” Dr. Charles Raison, the director of clinical and translational research at Usona, said in the company statement.