The U.S. Food and Drug Administration (FDA) has granted psilocybin (naked mushroom sin either or celosib) a breakthrough treatment for the second time,media reported, in an effort to speed up trials to test its treatment for severe depression (MDD). As early as the end of 2018, the FDA qualified compass for COMPASS Pathways’ ongoing research on breakthrough therapies, which investigated psilocybin, an important psychoactive compound in magical mushrooms, as a treatment for drug-resistant depression. A large, multi-center Phase 2 clinical trial spanning the United States, the United Kingdom and Europe is currently testing various drug strategies.
The new FDA Breakthrough Therapy approved is primarily a Phase 2 clinical trial at seven sites currently conducted in the United States. The trial, coordinated by a non-profit research organization called the Usona Institute, is studying the antidepressant properties of a single dose of psilocybin in the treatment of patients with severe depression.
Last year’s breakthrough treatment was named for patients with refractory depression (TRD). This specific clinical classification classifies patients with MDD who did not respond effectively to at least two different pharmacopharmaceutical antidepressant treatments during the current onset of depression. It is estimated that 10% to 30% of MDD patients are TRD.
The FDA’s new approval focuses on Usona’s study of the broader MDD condition, characterized by severe depressive episodes that last more than two weeks. Hundreds of millions of people around the world suffer from this severe form of depression every year.
Charles Raison, head of clinical and translational research at Usona, said: “Previous studies have clearly demonstrated the huge potential of psilocybin as a treatment for MDD patients, and Usona is now trying to prove this in its own clinical trials. What’s really groundbreaking is that the FDA rightly acknowledges that MDD not only represents low-resistance depression, but also meets unmet medical needs, and that available data suggest that psilocybin can provide substantial clinical improvements over existing therapies. “
The FDA introduced the Breakthrough Therapy designation in 2012 to provide faster approval for treatment-advantaged drugs in serious or life-threatening diseases than currently selected. In addition to providing development assistance to any organization sponsoring the study, the name is also considered a positive recognition of the accuracy and social impact of the expected treatment. To date, about a third of treatments that have been awarded the title of Breakthrough Therapy have finally been recognized by the market.
The Usona Phase 2 pilot program enrolled 80 subjects who randomly received any single active dose of psilocybin or an active placebo containing niacin. The method satout is similar to other psilocybin treatment studies, in which patients underwent a number of prep psychotherapy treatments prior to an effective psychedelic dose, followed by a number of comprehensive psychotherapy.
Since the trial is studying the effects of single-dose psilocybin, the study will provide some interesting insightinto into the potential widespread use of psychedelics in the treatment of general depressive episodes, contrary to the efficacy of other studies in more severe cases of multiple doses. Usona estimates that the current Phase 2 trial should be completed by early 2021, and that, with the help of the FDA’s breakthrough therapy designation, it should be able to move quickly into the larger Phase 3 trial if the results are positive.
The previously discussed COMPASS trial for psilocybin for treatment of refractory depression should be completed sometime in 2020, suggesting that convincing and reliable data will be available over the next 12 to 24 months. This new psilocybin therapy has been shown to be effective in treating several different forms of depression.
“Given the high complexity of psilocybin and the fact that Usona is opening up new markets, these interactions will ensure that Usona and fda are consistent in developing development plans with acceptable best practices.” Raison said.