BYFAVO (remimazolam)(Information obtained and shared from product website https://byfavo.com/ )

Byfavo^®: A Short-Acting Sedative for Procedures 30 Minutes or Less

Rapid Onset of Action

Onset of sedative effects of 1.0-1.5 minutes^1,* and median time to peak sedation was 3.0-3.5 minutes after initial 5 mg dose.²

Rapid Offset of Action

Median time to fully alert was 11.0-14.0 minutes following last dose.²

Rapidly Metabolized

CYP450-independent metabolism with no active metabolite resulting in a terminal half-life of 37-53 minutes.²

The soft drug approach is a strategy where compounds are specifically designed to be vulnerable to rapid biotransformation into inactive metabolites.^3,5

Mechanism of Action

Byfavo is a benzodiazepine. Like other benzodiazepines, Byfavo binds to GABA_A receptors in the brain, while its carboxylic acid metabolite (CNS7054) has a 300 times lower affinity for the receptor. Byfavo, like other benzodiazepines, did not show clear selectivity between subtypes of the GABA_A receptor.²

Soft, Ester-Based Drug Design

Remimazolam was derived from midazolam.³ The molecular structure of remimazolam differs from midazolam, and all other benzodiazepines, due to the addition of the carboxylic ester linkage.⁴ The addition of a carboxylic ester linkage creates a “soft drug.”⁵ The soft drug approach is a strategy where compounds are specifically designed to be vulnerable to rapid biotransformation into inactive metabolites.^3,5 This approach was used for the development of remifentanil, a nonhepatically metabolized fentanyl derivative.^5,6

Characteristic Benzodiazepine Safety Profile

Established Safety in a Diverse Range of Adult Patients Across 3 Clinical Trials

Common Adverse Reactions Occurring at >2% in Any Treatment Group

Data reflect exposure to Byfavo in 630 ASA I-IV patients pooled from the three placebo-controlled Phase 3 studies.¹

The most common adverse reactions (>10%) in patients receiving Byfavo for procedural sedation were hypotension, hypertension, diastolic hypertension, systolic hypertension, hypoxia, and diastolic hypotension¹

Patients receiving Byfavo experienced less hypotension than those receiving placebo with midazolam¹

https://byfavo.com/dosing-and-administration/