Psilocybin Takes Next Step Towards FDA Approval

Clinical trials for psilocybin will enter the final stage after successful results in a recent study.

Compass Pathways announced positive results from its phase 2 clinical trials for the drug, a psychedelic that is derived from a plant known as “magic mushrooms.” The company hopes to use it as a treatment for post-traumatic stress disorder (PTSD).

The trial was performed to establish the safety of using the drug, and was not focused on its results in alleviating the symptoms of the condition. For this trial, 22 adults were given a single 25 mg dose of a psilocybin treatment developed by Compass, named COMP360.

Participants are to be monitored for 12 weeks after they receive the dose to gather information on any adverse reactions. Full results are expected to be published in spring 2024.

“Safety is of paramount importance when developing potential new treatments, so we are pleased to see these positive safety signals,” Guy Goodwin, M.D., the company’s chief medical officer, said in a statement. “These results are consistent with findings from other studies and add to the growing body of evidence to demonstrate the potential of COMP360 in difficult-to-treat mental health conditions.”

The results come as part of a larger push to legalize the once-taboo class of psychedelic drugs so they can be used to treat a multitude of mental health conditions. Last week, the popular party drug MDMA was submitted to the Food and Drug Administration (FDA) for approval to treat PTSD. A decision on the approval is expected within the next year.

Many are also hoping that ketamine can emerge as a treatment for severe cases of depression and anxiety. Ketamine has already received FDA approval as an anesthetic, and is used off-label to treat mental health conditions at clinics across the country. However, many doctors warn against using these clinics.

Psilocybin has also shown positive results treating other mental health conditions, including a new study earlier this month that found it could be a tool for bipolar disorder. It has also shown promise treating depression.

Compass is set to launch phase 3 trials for COMP360 after the conclusion of phase 2. These trials, the last before submission for FDA approval, are generally to test for a drug’s effectiveness treating the targeted condition.

“It’s encouraging to see these initial safety results for COMP360 psilocybin treatment in this patient population and we look forward to a more detailed analysis of the study next year,” James Rucker, M.D., a psychiatrist from King’s College London who is consulting with Compass, said in a statement.