Biotechnology company Compass Pathways has completed its new drug application to the FDA for COMP360, an investigational synthetic psilocybin formulation for treatment-resistant depression, the company said Nov. 9.
The application rests on two phase 3 trials and a phase 2b study. Each met its primary endpoint, and together they enrolled more than 1,000 patients with chronic treatment-resistant depression.
Compass expects to launch COMP360 in the first half of 2027 if the FDA approves it. The FDA had already granted the drug rolling review and a Commissioner’s National Priority Voucher, which could shorten the review timeline. COMP360 contains a Schedule I controlled substance, so the Drug Enforcement Administration and states must also reschedule it before Compass can sell it in the U.S.
Treatment-resistant depression is defined as an inadequate response to at least two courses of antidepressants at an adequate dose and duration. An estimated 4 million people in the U.S. live with the condition, and fewer than 5% receive a treatment indicated for it, according to the company.
Kabir Nath, CEO of Compass Pathways, said patients with treatment-resistant depression “have gone too long experiencing disproportionate suffering” despite years of trying existing treatments.
Mr. Nath said Compass has a fully scaled commercial organization and the infrastructure in place to support broad patient access once the drug is approved.
COMP360 holds FDA breakthrough therapy designation, and Compass is also running a late-stage trial of the drug for post-traumatic stress disorder.
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