Sedation

Byfavo was shown to be effective at sedating patients undergoing colonoscopy (a procedure to examine the colon through a tube with a camera) or bronchoscopy (a procedure to examine the lungs and airways using a thin, tube-like instrument) in two main studies.

In the first study, involving 461 patients, the colonoscopy was successful without the need for a significant number of top-ups or an alternative sedative medicine in about 91% (272 out of 298) of patients who received Byfavo. This compares with 2% (1 out of 60) of patients receiving placebo (a dummy treatment) and 25% (26 out of 103) of those receiving midazolam, another sedative medicine.

In the second study, involving 446 patients undergoing bronchoscopy, these figures were 81% (250 out of 310) with Byfavo, 5% (3 out of 63) with placebo and 33% (24 out of 73) with midazolam.

In both studies, the sedative effect of Byfavo started and wore off within minutes.

General anaesthesia

The efficacy of Byfavo for bringing about and maintaining general anaesthesia was shown to be comparable to that of propofol in two main studies. The first study involved 365 adults who underwent surgery and measured the time patients spent unconscious with a Narcotrend Index below or equal to 60 (Narcotrend Index is a measure of brain activity which indicates the level of unconsciousness caused by general anaesthesia. It ranges from 100 [awake] to 0 [very deep hypnosis]), with values below 60 associated with a low likelihood of consciousness). Patients given Byfavo had on average a Narcotrend Index score of 60 or below for 95% of the time during surgery. This compared to 99% of the time in patients given propofol.

In the second study, involving 391 adults who underwent surgery, loss of consciousness was achieved and maintained in 99% of patients given Byfavo and 100% of patients given propofol. The main measure of efficacy was the successful conduct of the surgery, measured by a lack of body movements and the absence of awakening or recall of the surgical procedure, and the need for other medications to maintain general anaesthesia during surgery.