Compass Pathways has completed its submission of a New Drug Application to the U.S. FDA for COMP360 psilocybin, its investigational synthetic, proprietary formulation of psilocybin, for treatment-resistant depression (TRD).
The submission supported by data from two highly statistically significant phase 3 trials and a phase 2b study that each met its primary endpoint and involved a total of more than 1,000 participants living with highly chronic TRD.
Back in April, the FDA granted Compass’ NDA rolling review request and selected COMP360 for the Commissioner's National Priority Voucher (CNPV) program for TRD. The voucher gives companies benefits such as enhanced communications and a shortened 1-2 month review time following filing of an NDA.
COMP360 is administered as a single oral capsule in a controlled, supervised clinical setting. According to Compass, the company has deep commercial capabilities in place to enable successful launch execution and broad patient access with launch readiness on track for expected launch in H12027, subject to FDA approval.
“We look forward to continuing the review process, and we are focused on delivering COMP360 to patients as quickly as possible, subject to FDA approval. We have a world-class and fully scaled commercial organization, and the infrastructure and capabilities in place to support broad patient access upon approval,” said Kabir Nath, CEO of Compass Pathways.