Byfavo (remimazolam; Acacia Pharma) is now available for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. 

Byfavo, a Schedule IV controlled substance, is a rapid-acting, reversible benzodiazepine with peak sedation occurring approximately 3 to 3.5 minutes after an initial dose of 5mg given intravenously over a 1-minute period.

The approval was based on efficacy and safety data from 3 multicenter, randomized, double-blind phase 3 studies that compared Byfavo to a saline placebo with midazolam rescue treatment group and an open-label midazolam treatment group in 969 adult patients undergoing colonoscopy (Study 1 and Study 2) or bronchoscopy (Study 3) procedure. Results from these studies showed statistically significantly higher sedation success rates with Byfavo compared with placebo.

The most common adverse reactions (incidence of greater than 10%) reported with Byfavo included hypotension, hypertension, diastolic hypertension, systolic hypertension, hypoxia, and diastolic hypotension. 

The labeling of Byfavo includes a Boxed Warning regarding appropriate training of personnel as well as the equipment needed for monitoring and resuscitation. Additionally, the Boxed Warning addresses the risks associated with concomitant use of Byfavo with opioid analgesics or other CNS depressant medications. 

Byfavo is supplied in single-use vials as 20mg of remimazolam (equivalent to 27.2mg remimazolam besylate) lyophilized powder for reconstitution.

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Acacia Pharma launches Byfavo™ (remimazolam) in the United States for procedural sedation in adults undergoing medical procedures lasting 30 minutes or less. [press release]. Cambridge, UK and Indianapolis, IN: Acacia Pharma; January 28, 2021.