BRIDION (Sugammadex) Received FDA Approval For The Reversal Of Neuromuscular Blockade Induced By Rocuronium And Vecuronium In Adults Undergoing Surgery

Merck announced that the U.S. Food and Drug Administration (FDA) has approved 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.

One hundred fifty-seven patients were evaluated in a phase 3, multicenter, randomized, parallel-group, active-controlled safety assessor-blinded clinical study. In the study, patients received either rocuronium or vecuronium and underwent elective surgical procedures under general anesthesia that required endotracheal intubation and maintenance of neuromuscular blockade. At 1-2 PTCs (deep block), after the last dose of rocuronium or vecuronium, 4 mg/kg BRIDION or 70 mcg/kg neostigmine was administered. The time from the start of administration of BRIDION or neostigmine to recovery of the train-of-four (T4/T1) ratio of 0.9 was assessed. Generally, a T4/T1 ratio =0.9 correlates with recovery from neuromuscular blockade. Neostigmine was not expected to reverse neuromuscular blockade at a depth of 1-2 PTCs.

Patients treated with BRIDION achieved rapid recovery of neuromuscular function from rocuronium-induced (n=37) deep block (1-2 PTCs) in a median time of 2.7 minutes with a 25th and 75th percentiles of 2.1 and 4.3 minutes respectively, and from vecuronium-induced (n=47) deep block in a median time of 3.3 minutes with a 25th and 75th percentiles of 2.3 and 6.6 minutes, respectively. There were 7 and 6 censored observations in the rocuronium and vecuronium groups, respectively.

An additional phase 3, multicenter, randomized, parallel-group, active-controlled safety assessor-blinded clinical study evaluated 189 patients who received either rocuronium or vecuronium and underwent elective surgical procedures under general anesthesia that required endotracheal intubation and maintenance of neuromuscular blockade. At the reappearance of the second twitch (moderate block), after the last dose of rocuronium or vecuronium, 2 mg/kg BRIDION or 50 mcg/kg neostigmine was administered. The time from the start of administration of BRIDION or neostigmine to recovery of the train-of-four (T4/T1) ratio of 0.9 was assessed.

Patients treated with BRIDION (n=48) achieved faster recovery of neuromuscular function from rocuronium-induced moderate block in a median time of 1.4 minutes with a quartile 1 and quartile 3 of 1.2 and 1.7 minutes, respectively, versus a median time of 21.5 minutes with a quartile 1 and quartile 3 of 9.8 and 42.0 minutes, respectively with neostigmine (n=48). Reversal of vecuronium-induced moderate NMB with BRIDION (n=48) occurred in a median time of 2.1 minutes with a quartile 1 and quartile 3 of 1.8 and 3.4 minutes, respectively, versus 29.0 minutes with a quartile 1 and quartile 3 of 12.2 and 76.2 minutes, respectively with neostigmine (n=45).