WASHINGTON – Federal health authorities have approved a new drug that helps patients recover from the numbing effects of certain surgical drugs.
The approval of Bridion marks a victory for Merck & Co. Inc., which had been seeking marketing clearance for the injectable medication for years.
Bridion is the first drug that reverses the effects of certain muscle-relaxing drugs given along with anesthesia during surgery. Patients treated with Bridion recovered faster from surgery than those who did not receive the drug, according to the FDA’s review of studies involving 456 patients.
But the FDA first rejected the drug in 2008 due to allergic reactions and bleeding problems seen in some patients. The agency then repeatedly cancelled and rescheduled meetings to review the drug, most recently in March of this year.
The drug was approved in European Union countries in 2009.
The most common side effects seen in company trials included vomiting, pain, headache and low blood pressure. Rare severe allergic reactions and slow heart pumping were also recorded.
A spokeswoman for Whitehouse Station, N.J.-based Merck said the drug would be available in January 2016.
Bridion was first developed by rival Schering-Plough Corp., which Merck acquired in November 2009 for roughly $41 billion.