After further clinical trials, Merck & Co Inc.'s injection Bridion (sugammadex) has received approval from the United States Food and Drug Administration (FDA). The drug reverses the effects of muscle relaxants following surgery.
Neuromuscular blocking drugs such as vecuronium bromide and rocuronium bromide can cause brief paralysis as they interfere with the transmission of nerve signals to the muscles. These relaxants paralyze the vocal cords for tracheal intubation, a process in which doctors insert an artificial airway for patients during surgery.
Both muscular relaxants can also put patients immobile during surgery while they receive general anesthesia. They also prevent patients from automatically breathing when they are placed on a ventilator.
Dr. Sharon Hertz, director of the Division of Anesthesia, Analgesia and Addiction Products in FDA's Center for Drug Evaluation and Research, said that Bridion offers a new treatment option for patients, which may help speed up recovery from medications used for ventilation or intubation. She said the drug will be able to restore spontaneous breathing after surgical operations.
To assess the efficacy and safety of Bridion, scientists evaluated the drug in three Phase 3 clinical trials that included 456 individuals. The time to recover after surgery was faster for the Bridion treatment compared to other groups. Most of the individuals recovered within five minutes of routine use of sugammadex.
The drug was also further tested due to potential risks of hypersensitivity reactions and anaphylaxis, a life-threatening allergic reaction, which were all reported in the first trials.
In a double-blind, repeat-dose, parallel-group and randomized trial, 299 participants were treated with Bridion. One participant was reported to experience anaphylaxis.
"Clinicians should be aware of the possibility of a hypersensitivity reaction or anaphylaxis and should intervene as appropriate," the FDA cautioned.
Meanwhile, experts from Thomson Reuters data estimated Bridion will generate annual sales of $557 million within five years.
Bridion was originally created by Organon BioSciences, a company acquired by Schering-Plough eight years ago. Merck acquired Bridion when it bought Schering-Plough in 2009. The FDA rejected the approval of the drug in 2008, citing concerns about potential bleeding and allergic reactions.
In November this year, a panel recommended sugammadex for FDA approval as the drug satisfied the risk-benefit ration.
Photo: Nathan Forget | Flickr
