Byfavo® (remimazolam) is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic. It is a sedation agent for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. It is characterized by a very rapid onset and offset.
The product is faster than the available alternatives of the same pharmaceutical class for the same indication (e.g. midazolam) and is safer than other alternatives for the same indication (e.g. propofol). Byfavo® can be reversed with flumazenil to rapidly terminate sedation or anesthesia if necessary.
Paion announced positive data in the Byfavo® phase III trials respectively in patients undergoing colonoscopy and bronchoscopy and in high risk (ASA III/IV) patients.
Byfavo® was in-licensed from Paion in June 2016, was sub-licensed by Cosmo to Acacia Pharma in January 2020.
Byfavo® was approved by the US Food and Drug Administration (FDA) in July 2020.
In January 2021, Acacia Pharma launched Byfavo® in the US. Approximately 40 million procedures take place annually in the US that require the use of procedural sedation.
The licence agreement is between Paion and Acacia (Eagle Pharmaceuticals acquired Acacia in mid-2022) and Cosmo has the potential to receive commercial milestones of up to $105m.
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