In November 2019, the US Food and Drug Administration (FDA) granted psilocybin therapy a breakthrough status for depression. This recognition makes it the second time in a year the FDA would designate such a status to psilocybin, the hallucinogenic compound in psychedelic mushrooms. The FDA’s action is meant to fast-track the typical slow process of drug development and review. Breakthrough status recognition is typically requested and granted only when there is preliminary evidence that suggests a therapy has the potential to provide a substantial improvement over already available therapy.
Breakthrough Status for Psilocybin Research by COMPASS Pathways
In October 2018, the FDA granted Breakthrough Therapy status to psilocybin therapy in the ongoing clinical trials being conducted by a British life sciences organization, COMPASS Pathways. COMPASS is investigating the potential of the psychoactive compound in magic mushrooms effect on treatment-resistant depression (TRD). TRD refers to a type of depression that has defied other treatment options tried by a patient. Specifically, the clinical trial by COMPASS focuses on patients suffering from Major Depressive Disorder (MDD) who haven’t responded well to at least two different antidepressants treatments. An estimated 10% to 30% of MDD patients suffer from this type of TRD.
Breakthrough Status for Psilocybin Research by Usona
This time around, the latest FDA’s breakthrough therapy status is for a clinical trial by a US-based organization, Usona Institute. The Usona’s work focuses on treating MDD patients with a single dose of psilocybin. It is narrowed down to patients who experience episodes of severe depression that last for more than two weeks. According to a statement from Usona Institute, more than 17 million people across the world experience this type of depression. The company further stated that psilocybin has the potential to profoundly impact the brain and wipe away depressive symptoms, thereby leading to a long-lasting benefit.
With more than 300 people across the globe suffering from depression, this groundbreaking potential by psilocybin could signal a significant milestone in the treatment of depression, which is also the world’s leading cause of disability. According to Dr Charles Raison, the director of clinical and translational research at Usona, the groundbreaking FDA’s acknowledgement shows that MDD “represents an unmet medical need and that the available data suggest that psilocybin may offer a substantial clinical improvement over existing therapies.”
Breakthrough Status to Fast-Track the Next Phase
With this designated status, phase 2 of this work by Usona is expected to complete by early 2021. This will also propel the trial to move quickly to its phase 3 trial, going by the past occurrences in previous therapies that received such recognition. Around one-third of treatments that previously received a Breakthrough Therapy status have progressed on to get market approval.
Phase 2 of the Usonal’s research plans to enroll 80 participants where each person will receive either a single dose of psilocybin or a placebo containing niacin. This method is quite similar to other psilocybin studies. And as the trial progresses, there would be a broader perspective on the efficacy of this psychedelic agent in treating the depressive disorder with a single dose, compared to other work focusing on treating depression with multiple doses.
Psychedelics: A Potential Game-Changer for Depression Treatment
It is worth noting also that this is not the first time a psychedelic substance would receive such a laudable recognition by the FDA. In March 2019, the FDA approved ketamine nasal sprays for the treatment of treatment-resistant depression. With these recent achievements, there is a possibility that psilocybin and other psychedelics could be a game-changer in the treatment of depression and other emotional sufferings.