Long-awaited surgery drug gets FDA OK

FDA approved Bridion (sugammadex) injection today – after a long wait by Merck & Co. – to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide, used during certain types of surgery.

Bridion is marketed by Merck Sharp and Dohme Corp., a subsidiary of Merck and Company. Merck acquired the drug in 2009 as part of its takeover of Schering-Plough.

However, the FDA rejected Schering-Plough’s original application in 2008, citing concerns about possible allergic reactions and increased risks of bleeding when it was used with certain blood-thinning drugs, according to The Wall Street Journal.

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Then, the agency rejected Merck’s application for Bridion in 2013, citing operational concerns.

However, after its approval this week, Sharon Hertz, MD, director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA’s Center for Drug Evaluation and Research, said that the drug “enables medical personnel to reverse the effects of neuromuscular blocking drugs and restore spontaneous breathing after surgery.”

The safety and efficacy of Bridion were evaluated in three phase 3 clinical trials involving 456 participants. The return to recovery time was faster overall for the Bridion treatment groups compared to the comparator groups, with most participants recovering within 5 minutes of routine use of Bridion.

And, due to concerns about anaphylaxis reactions reported in the clinical trials, 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. “Clinicians should be aware of the possibility of a hypersensitivity reaction or anaphylaxis and should intervene as appropriate,” the FDA said in a statement.

FDA also said that 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 Bridion. “Patients should be closely monitored for hemodynamic 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,” FDA said.

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 Bridion may temporarily reduce the contraceptive effect so they must use an alternate method of birth control for a period of time.

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