Remimazolam, sold under the brand nameByfavo, is amedication for the induction and maintenance ofprocedural sedation in adults for invasive diagnostic or surgical procedures lasting 30 minutes or less.[2][5][6] It is abenzodiazepine drug, developed by PAION AG in collaboration with several regional licensees as an alternative to the short-acting imidazobenzodiazepinemidazolam, for use in the induction of anesthesia and conscious sedation for minor invasive procedures.
Remimazolam was found to have both a more rapid onset and a shorter duration than midazolam, and humanclinical trials showed a faster recovery time and predictable, consistent pharmacokinetics, suggesting some advantages over existing drugs for these applications.[7][8]
Remimazolam was approved for medical use in the United States in July 2020.[5][6]
The U.S.Food and Drug Administration (FDA) approved remimazolam based on evidence from three clinical trials (Trial 1/NCT02290873, Trial 2/NCT02296892 and Trial 3/NCT02532647) in adults undergoing short procedures.[5] Trials were conducted at 32 sites in the United States.[5]
Trials 1 and 3 were conducted in participants undergoing colonoscopy and Trial 2 was conducted in participants undergoing bronchoscopy procedures.[5]
In the trials, participants were randomly divided in three groups: one group received remimazolam, one group received placebo and one group received midazolam (similar, but approved drug).[5] In the first two groups, neither participants nor investigators knew which medications were given and participants could also receive midazolam as a rescue drug when needed for sedation.[5] In the third group, all participants received midazolam only[5] Additionally, in all three trials participants received a medication for pain control[5]
Trials 1 and 2 compared participants who received remimazolam to participants in the other two groups, measuring the success of sedation with the set of pre-determined criteria.[5] Data from Trial 3 were used primarily to assess the side effects of remimazolam when multiple dosing is used.[5]
On 28 January 2021, theCommittee for Medicinal Products for Human Use (CHMP) of theEuropean Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Byfavo, intended for procedural sedation.[10] The applicant for this medicinal product is PAION Netherlands B.V.[10] Remimazolam (Byfavo) was approved for medical use in the European Union in March 2021.[3]
Phase I[11] and Ib[12] dose-finding studies for procedural sedation with patients recovering faster from remimazolam than midazolam. Phase II trials comparing remimazolam to the standard anesthesia protocols for cardiac surgery and colonoscopy were presented at major conferences in October 2014.[13]
A Phase IIa trial comparing remimazolam to midazolam for upper endoscopy was published in December 2014, finding a similar safety profile.[14] Remimazolam was originally synthesized in the late 1990s atGlaxo Wellcome in their labs inResearch Triangle Park,North Carolina.[15][16][17]
^abc"Byfavo EPAR".European Medicines Agency (EMA). 9 December 2020. Retrieved20 April 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^Rogers WK, McDowell TS (December 2010). "Remimazolam, a short-acting GABA(A) receptor agonist for intravenous sedation and/or anesthesia in day-case surgical and non-surgical procedures".IDrugs.13 (12):929–937.PMID21154153.
^Saari TI, Uusi-Oukari M, Ahonen J, Olkkola KT (March 2011). "Enhancement of GABAergic activity: neuropharmacological effects of benzodiazepines and therapeutic use in anesthesiology".Pharmacological Reviews.63 (1):243–267.doi:10.1124/pr.110.002717.PMID21245208.S2CID930379.
^ab"Byfavo: Pending EC decision".European Medicines Agency. 29 January 2021. Archived fromthe original on 22 February 2021. Retrieved25 February 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
Clinical trial numberNCT02290873 for "A Phase III Study of the Efficacy and Safety of Remimazolam Compared to Placebo and Midazolam in Colonoscopy Patients" atClinicalTrials.gov
Clinical trial numberNCT02296892 for "A Phase III Study of Remimazolam in Patients Undergoing Bronchoscopy" atClinicalTrials.gov
Clinical trial numberNCT02532647 for "Safety and Efficacy of Remimazolam in ASA III and IV Patients Undergoing Colonoscopy" atClinicalTrials.gov
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