BYFAVO™ (remimazolam) is an ultra-short-acting and reversible intravenous benzodiazepine sedative/anesthetic, designed for use during invasive medical procedures such as colonoscopy and bronchoscopy. Its use can induce very rapid onset of sedation and quick post-procedure recovery. It can be reversed with flumazenil to terminate sedation or anesthesia rapidly if necessary.
The efficacy and safety of BYFAVO have been investigated as part of an extensive clinical trial program involving approximately 2,400 volunteers and patients. Positive Phase 3 data in patients undergoing colonoscopy and bronchoscopy have been achieved and an NDA for BYFAVO has been submitted to the FDA with a target review (PDUFA) date of 5 July 2020.
Acacia in-licensed the US rights to BYFAVO from Cosmo Pharmaceuticals in January 2020. Cosmo in-licensed the US rights to BYFAVO from Paion AG in 2016 and together they have progressed the product candidate through to NDA filing.