Updated on 22 December 2015
Merck has recieved USFDA approval for Bridion (sugammadex) Injection 100 mg/mL
Singapore: Merck (MSD) has recieved US Food and Drug Administration (FDA) approval for Bridion (sugammadex) Injection 100 mg/mL (equivalent to 108.8 mg/mL sugammadex sodium) for the reversal of neuromuscular blockade (NMB) induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery.
Bridion works differently than neostigmine, an agent used to reverse non-depolarizing neuromuscular blocking agents (NMBAs) by increasing the neurotransmitter acetylcholine at the neuromuscular junction. Bridion forms a complex with the non-depolarizing NMBAs rocuronium and vecuronium, thereby removing these agents from the neuromuscular junction and facilitating the return of muscle function. Unlike neostigmine, Bridion can be used to reverse different levels of rocuronium and vecuronium-induced NMB, including deep block (1-2 post-tetanic counts [PTCs]).
"The FDA approval of Bridion reflects Merck's continued commitment to develop medicines that address unmet needs," said Dr David Michelson, vice president, Neurosciences, Merck Research Laboratories. "With Bridion, we now have a new option with a different mechanism of action to reverse neuromuscular blockade induced by rocuronium and vecuronium in adults undergoing surgery."
Bridion is contraindicated in patients with known hypersensitivity to sugammadex or any of its components. Hypersensitivity reactions that occurred varied from isolated skin reactions to serious systemic reactions and have occurred in patients with no prior exposure to sugammadex.