Health · Pharma & Biotech · 2 hrs ago
Compass Pathways plans cautious rollout of its experimental psychedelic treatment
Compass Pathways is preparing to seek FDA review for COMP360, its synthetic psilocybin treatment for treatment-resistant depression.
The company aims to complete its submission this quarter and hopes to launch early next year if regulators approve the treatment.
Psilocybin differs from standard antidepressants, which are usually taken daily and can take weeks to work; COMP360 is given in a supervised session lasting about six hours.
In the company’s Phase 3 trials, about one-quarter of patients responded after one dose, rising to about 40% after a second dose three weeks later.
CEO Kabir Nath says some patients who respond may benefit for up to a year after two or three administrations, and the company is training providers for a careful rollout.
Researchers say important questions remain about how the treatment works, including whether the psychedelic experience itself is necessary and how to measure results when patients know they received the drug.
The FDA may require safety controls, and the field’s first potential approval could depend on addressing these questions while avoiding poor early experiences that could harm confidence in psychedelic treatments.
Compass Pathways is preparing to complete its rolling FDA submission this quarter for COMP360, a synthetic psilocybin treatment for treatment-resistant depression.
CEO Kabir Nath says the company plans a cautious rollout, warning that poor early experiences could damage the broader psychedelics sector.
If approved, Compass aims to launch the treatment early next year and expects it to be subject to an FDA risk evaluation and mitigation strategy.
In Phase 3 trials, about a quarter of patients had a clinically meaningful response after one administration, rising to about 40% after a second dose.
Researchers say questions remain about trial blinding and the roles of the psychedelic experience and psychotherapy in treatment benefits.
- Who
- Compass Pathways, led by CEO Kabir Nath, is preparing the treatment. Steven Hyman raised scientific questions about psychedelic treatments.
- What
- Compass is preparing to submit COMP360, a synthetic psilocybin treatment for treatment-resistant depression, for FDA review.
- When
- The company plans to complete its rolling submission this quarter and aims to launch early next year if approved.
- Where
- Nath spoke at the STAT Summit in Boston.
- Why
- Compass says a cautious rollout is important because negative early experiences could damage the broader sector.
Compass Pathways
Steven Hyman
Psychotherapy
Compass Pathways
Nath said Compass separated psychotherapy from its trials and that the company’s responsibility is to develop a drug, not dictate psychological care.
Steven Hyman
Hyman said psychotherapy after a psychedelic experience could help patients process its effects.
Treatment effects
Compass Pathways
Nath cited longer-term data suggesting benefits for responding patients can last as long as a year after two or three administrations.
Steven Hyman
Hyman said researchers have yet to determine how much benefit comes from the drug’s pharmacological effects and how much from the experience itself.
Nath spoke at the STAT Summit in Boston about Compass’s plans for a cautious rollout.
Compass is preparing to complete its rolling FDA submission for COMP360.
Compass aims to launch COMP360.
- Treatment
- COMP360, a synthetic psilocybin treatment for treatment-resistant depression
- FDA submission
- Rolling submission completion planned for this quarter
- Phase 3 response after one administration
- Roughly 25% of patients had a clinically meaningful response
- Phase 3 response after a second dose
- About 40% of patients had a clinically meaningful response
- Second dose timing
- Three weeks after the first administration
- Supervised session
- Roughly six hours
What people are saying
go slow before we go fast
The unblinding remains a challenging problem
But we don’t know.