FDA approves Bridion (sugammadex) to reverse rocuronium bromide and vecuronium bromide neuromuscular blockade- Merck

The FDA has approved Bridion (sugammadex) injection from Merck, to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide, which are used during certain types of surgery in adults.

Rocuronium bromide and vecuronium bromide are neuromuscular blocking drugs that cause temporary paralysis by interfering with the transmission of nerve impulses to the muscle and are used to paralyse the vocal cords when patients require an artificial airway or breathing tube for surgery, a process called tracheal intubation. They can also be used to prevent patients from moving during surgery while they are receiving general anesthesia. Neuromuscular blocking drugs are also sometimes used to prevent the body from breathing automatically when a patient has to be placed on a ventilator.

The safety and efficacy of sugammadex were evaluated in three Phase III clinical trials involving 456 participants. The return to recovery time was faster overall for the sugammadex treatment groups compared to the comparator groups, with most participants recovering within 5 minutes of routine use of sugammadex. Due to concerns about the nature and frequency of anaphylaxis (severe, potentially life-threatening allergic reaction) and hypersensitivity reactions reported in the clinical trials, sugammadex was further evaluated in a randomised, double-blind, parallel-group, repeat-dose trial. Of the 299 participants treated with sugammadex, one person had an anaphylactic reaction. Clinicians should be aware of the possibility of a hypersensitivity reaction or anaphylaxis and intervene as appropriate. Cases of marked bradycardia (abnormally slow heart action), some of which have resulted in cardiac arrest, have been observed within minutes after the administration of sugammadex. Patients should be closely monitored for haemodynamic changes during and after reversal of neuromuscular blockade, and treatment with anticholinergic agents, such as atropine, should be administered if clinically significant bradycardia is observed. The most common adverse reactions reported in clinical trials included vomiting, low blood pressure (hypotension), pain, headache and nausea. Doctors should also advise women using hormonal contraceptives that sugammadex may temporarily reduce the contraceptive effect so they must use an alternate method of birth control for a period of time.

Bridion was EU approved in 2008.