FDA Approves COMPASS Pathways’s Psilocybin Clinical Trials

The United States Food and Drug Administration (FDA) has approved COMPASS Pathways’s clinical trials using psilocybin for treating depression, namely “Treatment Resistant Depression” (TRD).

In a statement released by COMPASS Pathways, 216 patients with treatment-resistant depression will take part in phase two clinical trial across 12 to 15 research sites in North America and Europe, which will start in the U.K. later this month. The clinical trial is a dose-ranging study, which aims to determine the best dose of psilocybin to use for treating TRD.

The U.S. FDA’s approval of COMPASS’s trial represents a significant departure from the government’s position that psilocybin, cannabis, and MDMA are “substances or chemicals … with no currently accepted medical use and a high potential for abuse.” See DEA Drug Scheduling. For many, this is perceived as the first step in correcting mistakes made in scheduling several promising drug treatments.

COMPASS Pathways’ Clinical Trials

As we reported previously, COMPASS Pathways is partnering with Worldwide Clinical Trials in conducting the first clinical trials for treating “Treatment Resistant Depression” (“TRD”) with psilocybin-assisted psychotherapy. See Financial Times, September 20, 2017.

The first round of clinical trials is focused on “Dose Finding,” which means determining the correct dosing regimen for treating TRD. The clinical trial participants “will be given synthetic psilocybin” in trials designed to determine the best dose of psilocybin–whether 1 mg, 10 mg, or 25 mg – is most effective.

Notably, COMPASS’s study is measuring the effects of a known amount of a known drug. Accordingly, the COMPASS studies already represent a significant improvement over existing psilocybin dosing methods, which rely on eating magic mushrooms. (Magic mushrooms contain many active ingredients in variable concentrations). See “COMPASS Pathways is NOT giving Magic Mushrooms to Depressed Patients.”

Significant Step Forward in Establishing Baseline Benefits

These studies by COMPASS Pathways represent a significant first step towards creating psilocybin based formulations. Improving our understanding of pure synthetic psilocybin treatments provides a baseline for studying formulations that leverage the full potential of magic mushrooms. See our article on the Entourage Effect which discusses the synergistic benefits of psilocybin derivatives and drawing an analogy to cannabis research. Akin to cannabis, once scientists have a baseline for how one component works in isolation, the community can quantify the benefits of specific combinations having optimized benefits and/or reduced side-effects.

Statements from COMPASS Co-Founders

George Goldsmith, Chairman and Co-founder of COMPASS Pathways, said, “We are excited to be starting this landmark trial which has the potential to transform lives. Depression is the leading cause of ill-health and disability worldwide, and treatment-resistant depression affects more than 100 million people. It is a huge unmet need and the trial will teach us more about how this new approach might address it.”

Ekaterina Malievskaia, Chief Medical Officer and Co-founder of COMPASS, said: “The design of this study has been a truly collaborative effort, with scientists, clinicians, patient representatives and regulators from Europe and North America working together with the goal of helping patients suffering with treatment-resistant depression.”