Breaking: Compass Files Psilocybin for TRD New Drug Application with FDA
This morning, Compass Pathways announced that it has submitted its COMP360 psilocybin for treatment-resistant depression (TRD) new drug application (NDA) to the FDA.
FDA is now reviewing three psychedelic NDAs, following the resubmission of Resilient Pharmaceuticals’ MDMA for PTSD applications this summer, and the filing of Usona Institute’s psilocybin for major depressive disorder (MDD) package more recently.
It means we could see FDA weigh in on the approvability of the first psychedelic in the coming weeks or months.
“The completion of our NDA submission reflects years of perseverance and commitment by patients, families, advocates, researchers and healthcare providers who have worked alongside us toward the shared goal of bringing new treatment options to this community,” Compass’ CEO, Kabir Nath, said this morning in a brief press release.
The company’s package features data from more than 1,000 participants, making it the largest cohort of any psychedelic drug development program.
The company has also been ramping up its commercialisation and sales efforts, targeting a H1 2027 launch.
Pα: For much, much more detail on Compass’ commercialisation plans and prospects, as well as competitive dynamics with Usona Institute, see Usona Files Psilocybin for Depression NDA as Race With Compass Tightens. ∎