Newly Approved Drug Reverses Effects of Neuromuscular Blocking Drugs Used During Surgery

In December, the U.S. Food and Drug Administration (FDA) approved Merck and Co.’s Bridion (sugammadex) injection to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide, neuromuscular blocking drugs used in certain types of surgery in adults to cause temporary paralysis by interfering with the transmission of nerve impulses to the muscle. Rocuronium bromide and vecuronium bromide are used to paralyze the vocal cords when patients require an artificial airway or breathing tube for surgery, a process called tracheal intubation; to prevent patients from moving during surgery when they are receiving general anesthesia; and to prevent the body from breathing automatically when a patient has been placed on a ventilator. “Bridion provides a new treatment option that may help patients recover sooner from medications used for intubation and ventilation during surgery,” said Sharon Hertz, MD, director of the division of anesthesia, analgesia and addiction products in FDA’s Center for Drug Evaluation and Research. “This drug enables medical personnel to reverse the effects of neuromuscular blocking drugs and restore spontaneous breathing after surgery.”

FDA approved Bridion after its evaluation in three Phase III clinical trials involving 456 participants. In the trials, return to recovery time was faster overall for the Bridion treatment groups compared with the comparator groups, with most participants recovering within five minutes of routine use of Bridion. Due to concerns of anaphylaxis and hypersensitivity reactions, Bridion was further evaluated in a randomized, double-blind, parallel-group, repeat-dose trial. Of the 299 participants treated with Bridion, one person had an anaphylactic reaction. The most common adverse reactions reported in clinical trials included vomiting, low blood pressure, pain, headache and nausea.