A key issue during the committee’s meeting was the updated safety profile of sugammadex. In clinical trials to date, the most common adverse reactions (incidence greater than 5 percent) seen with sugammadex in clinical trials were anesthetic complications generally due to restoration of muscle function (8.0 percent) and dysgeusia (12.6 percent). Based on animal studies, the drug might also adversely impact bones and tooth enamel in children, but Organon is seeking approval for adult use only. The FDA is not bound by the Anesthetic and Life Support Drugs Advisory Committee’s recommendations but generally gives them weight when considering New Drug Applications; the agency has granted the drug priority review status.
If granted approval, sugammadex will be the first and only selective relaxant binding agent (SRBA) and will give anesthesiologists the ability to rapidly and predictably shallow and profound depths of muscle relaxation induced by rocuronium and vecuronium within minutes, according to Organon. The drug works in an entirely novel way to encapsulate the muscle relaxant molecule and restore muscle function so that patients can breathe on their own again. It can be used in emergency situations to rapidly and immediately reverse, and allows for flexible dosing of muscle relaxation agents, letting anesthesiologists maintain optimal block through the end of the procedure, says Organon.
“We are very pleased with the outcome of today’s advisory committee meeting and appreciate the panel’s careful consideration of the data on sugammadex,” says Robert J. Spiegel, MD, chief medical officer and senior vice president, Schering-Plough Research Institute, in a prepared statement. “Sugammadex has the potential to transform the practice of anesthesia through improved management of muscle relaxation in the millions of surgeries where these agents are used. We will continue to work with FDA to bring sugammadex to the U.S. market as soon as possible so that anesthesiologists and their patients can benefit from this innovative product.”
