FDA Clears Compass Pathways to Begin Late Stage Psilocybin Trial for PTSD
The FDA accepted an Investigational New Drug application from Compass Pathways this week. The decision allows the company to launch a Phase 2b/3 clinical trial testing COMP360 psilocybin therapy for post traumatic stress disorder.
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| Key Takeaways | |
|---|---|
| Trial Phase | Phase 2b/3 (late stage) |
| Treatment | Single 25mg dose of COMP360 synthetic psilocybin |
| Target Condition | Post traumatic stress disorder |
| US Population Affected | 13 million annually |
| Current FDA Approved PTSD Drugs | 2 (both approved last century) |
| Phase 2 Results | 29.5 point reduction in symptoms at 12 weeks |
Why This Matters for PTSD Patients
The treatment landscape for PTSD has remained largely stagnant for decades. Only two medications have FDA approval for the condition. Both received clearance in the last century. Meanwhile, approximately 13 million Americans struggle with PTSD each year.
Notably, women represent 60% of those affected. Veterans and first responders face elevated risk, but PTSD reaches far beyond military populations. Survivors of assault, accidents, and natural disasters also develop the condition.
Promising Early Results
Compass Pathways published its Phase 2 findings in the Journal of Psychopharmacology. The open label study enrolled 22 patients across sites in the U.K. and U.S. A single 25mg dose produced rapid improvement that lasted through 12 weeks of follow up.
Researchers measured results using the CAPS-5 scale, the gold standard for PTSD assessment. Participants started with a baseline score of 47.5. By week four, scores dropped by 29.9 points. That improvement held steady at week 12 with a 29.5 point reduction.
Safety Profile Shows Promise
The treatment was generally well tolerated. No serious adverse events occurred during the study. The most common side effects included headache in 50% of participants and nausea in 36%. Some patients experienced crying, fatigue, and visual hallucinations.
Guy Goodwin, Chief Medical Officer at Compass Pathways, called the results “highly encouraging.” The company now moves forward with designing its late stage trial.
For those exploring alternative mental health treatments, this FDA decision represents meaningful progress. A new option may finally be on the horizon.
