FDA grants "revolutionary therapy" status to psilocybin in the treatment of depression

Psilocybin is an alkaloid, active principle of certain hallucinogenic mushrooms. In addition to its illicit recreational uses, the molecule has shown some potential for the treatment of certain psychological disorders and conditions by modifying brain chemistry. In order to accelerate the development and marketing of psilocybin-based therapeutic solutions, the FDA has declared the revolutionary treatment. It will be used especially in the context of major depressive disorders (MDD).

For the second time in a year, the US Food and Drug Administration (FDA) has designated psilocybin therapy - currently tested in clinical trials - as a revolutionary therapy, an action to accelerate slow process of development and testing. It is usually requested by a pharmaceutical company and granted only when preliminary evidence suggests that the drug could represent a significant improvement over the treatment already available.

Last year, the FDA granted psilocybin treatment as a breakthrough therapy in Compass Pathways' ongoing clinical trials investigating the potential of psilocybin to treat treatment-resistant severe depression. or depression in unimproved patients after two different antidepressant treatments.

A single dose of psilocybin to fight depression

At present, the FDA has granted this status to psychedelic treatment, this time for a US-based clinical trial conducted by the non-profit institution Usona Institute. This clinical trial, which includes 80 participants from seven different sites in the United States, focuses on the efficacy of treating patients with MDD with a single dose of psilocybin.

Synthetic route and structure of psilocybin. Credits: FDA

In the United States, more than 17 million people suffer from major depressive disorder or severe depression lasting more than two weeks. Psilocybin, in a single dose, could have a profound impact on the brain and have lasting effects after the elimination of depressive symptoms. The Phase 2 trial is expected to be completed early in 2021 and, with this status, Usona expects to move quickly to a larger Phase 3 trial.

Approximately one in three treatments that had previously received revolutionary therapy status was approved. " What is truly innovative is the FDA's legitimate recognition that MDD, and not just the smallest treatment-resistant depressive population, represents an unmet medical need and that the available evidence suggests that psilocybin may substantial clinical improvement over existing treatments, "says Charles Raison, director of clinical research at Usona.

Towards the use of psychedelics in the treatment of depressive disorders

This is not the first time that a psychedelic has been studied for its potential in the treatment of depression. In March, the FDA approved nasal spray treatment with Esketamine , a ketamine-related substance for treatment-resistant patients, an anesthetic that was also used as an illicit drug.

But we still know a lot about this approved drug. Although acting quickly, it is unclear how Esketamine modifies the brain, and therefore what its effects will be in the long term.


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