The Food and Drug Administration (FDA) has approved Byfavo™ (remimazolam; Acacia Pharma) for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. 

Byfavo 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 remimazolam 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.

Findings from Study 1 showed a colonoscopy sedation success rate (defined as a completion of the colonoscopy procedure without the need for rescue sedative medication and without a need for >5 doses of study drug within any 15-minute window) of 91.3% with remimazolam (n=272/298) compared with 1.7% for placebo (n=1/60). 

In Study 2, the primary end point was to assess the safety of multiple doses of remimazolam compared with placebo or midazolam. The total patient population included 31 patients in the remimazolam group, 16 patients in the placebo group, and 30 patients in the midazolam group. Results showed no serious adverse reactions and no discontinuations due to adverse reactions in the remimazolam group.

Among patients undergoing bronchoscopy (n=431), sedation success rate (defined as completion of the bronchoscopy procedure without the need for rescue sedative medication and without the need for >5 doses of study drug within any 15-minute window) was found to be statistically significantly higher in the remimazolam group compared with the placebo group (80.6% [n=250/310] vs 4.8% [n=3/63], respectively). 

With regard to safety, the most common adverse reactions reported with remimazolam included hypotension, hypertension, diastolic hypertension, systolic hypertension, hypoxia, and diastolic hypotension. 

The labeling for Byfavo includes a Boxed Warning regarding the 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. 

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“The approval of remimazolam (Byfavo) is very exciting for proceduralists as the field has not seen new sedation medications added to our armamentarium in decades,” said Gerard A. Silvestri, MD, MS, Professor of Medicine at the Medical University of South Carolina, Charleston, SC, and past-president of the American College of Chest Physicians. “The cardio-respiratory safety profile looked very encouraging and there was a rapid return of patients to consciousness enabling them to be discharged in a timely manner.”

The Company expects to launch Byfavo in the second half of 2020. Byfavo will be supplied as 20mg of remimazolam (equivalent to 27.2mg remimazolam besylate) in single-use vials. The drug is pending controlled substance scheduling by the Drug Enforcement Administration (DEA).

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