Magic Mushroom Ingredient Passes Major Test, Paving Way for FDA Approval

In two large-scale trials, Compass Pathways' proprietary form of psilocybin improved people's depression symptoms better than controls. The era of psychedelic medicine could be here sooner rather than later. Psilocybin, the primary ingredient in magic mushrooms, now appears to be inches away from receiving approval as a treatment for depression by the Food and Drug Administration. This week, Compass Pathways announced that its synthetic version of psilocybin passed both of the company’s large-scale clinical trials. Compared to controls, the drug significantly improved the outcomes of people with treatment-resistant depression (TRD), the studies found. The findings should clear the way for FDA approval, provided there are no unexpected hurdles. A new approach In recent years, psychedelics like psilocybin have been studied for their potential to treat various mental health conditions, usually in conjunction with other forms of therapy. Some studies have shown how these drugs can possibly rewire people’s brain activity in beneficial ways, while others have suggested they can help people who haven’t responded to other existing treatments. Could DMT Be a New Treatment for Depression? A Small Study Says Yes While several research teams and companies are developing psychedelic-based treatments, Compass Pathways has become the frontrunner with its proprietary form of psilocybin, currently named COMP360. Last June, the company reported the positive primary results of its first phase III trial of COMP360, COMP005. On Tuesday, it reported the primary findings of the second trial, COMP006. COMP005 involved 258 participants with treatment-resistant depression, and the first phase of the trial compared a single 25 milligram dose of psilocybin to a placebo, both of which were paired with psychological support. COMP006 involved 581 volunteers, who were given two doses of either 25 milligrams, 10 milligrams, or 1 milligram of psilocybin (the 1 milligram group served as a control). In both trials, the highest dose group saw a noticeable improvement in their depression symptoms compared to the control group. By six weeks, 25% of treated participants in COMP005 experienced “a clinically meaningful reduction” in their depression, the company reported; 39% of volunteers in the 25 milligram group in COMP006 experienced the same level of improvement by week 6. People who responded also saw improvement quickly, often within a day of treatment. And the drug seemed to be safe and well-tolerated, with most related adverse events being mild to moderate and nearly all fading away 24 hours later, according to the company. “This is a remarkable achievement for the field of psychiatry—especially in the TRD population, where proving benefit has historically been extraordinarily challenging,” said Kabir Nath, Compass Pathways CEO, in a statement from the company. The future of psilocybin for depression These findings, while positive, are likely less impressive than many would have hoped. On average, participants given 25 milligrams of COMP360 saw a roughly 4-point decline in the scale used to measure depression severity—a meaningful but modest improvement compared to controls. Psilocybin Therapy Changes Brain Wiring in Depressed People, Study Finds That said, treatment-resistant depression by its very nature is difficult to manage, so even a modest boost in mood might be worthwhile for many people. Simply having more options available for treatment-resistant depression is valuable, too, and unlike current antidepressants that typically take weeks to start working, psilocybin and other psychedelics tend to cause a rapid improvement in symptoms when effective, which could be important for treating an acute mental health crisis. Other research has also suggested that psilocybin can have a more profound, lasting effect on depression in general. Last September, for instance, a study found that 60% of people with major depression were in remission five years after participating in a clinical trial of psilocybin. Moderna Has a Promising New Flu mRNA Vaccine. Trump’s FDA Wants Nothing to Do With It Though both trials are still ongoing and tracking the longer-term outcomes of participants, with more results expected by early fall, Compass Pathways has stated it will formally file for FDA approval in the fourth quarter of this year. In ordinary times, such an approval would seem all but guaranteed. But we’re hardly living in ordinary times these days.