First-in-Class Drug Approved for Reversing Neuromuscular Blockers
The Food and Drug Administration (FDA) has approved Bridion (sugammadex; Merck) injection to reverse neuromuscular blockade induced by rocuronium bromide and vecuronium bromide.
Rocuronium bromide and vecuronium bromide are neuromuscular blockers used during certain surgeries for tracheal intubation, general anesthesia, and mechanical ventilation. Sugammadex is a first-in-class selective relaxant binding agent designed to work by inactivating rocuronium or vecuronium molecules directly by encapsulation.
The safety and efficacy of Bridion was studied in three Phase 3 clinical trials (n=456). For patient groups treated with Bridion, recovery time was faster overall compared to the comparator groups. Most patients recovered within 5 minutes of routine use of Bridion.
Bridion was further evaluated in a randomized, double-blind, parallel-group, repeat-dose trial due to concerns about anaphylaxis and hypersensitivity reactions observed in clinical trials. Of the patients treated with Bridion (n=299), one person had an anaphylactic reaction.
For more information visit FDA.gov.