Merck & Co. created a new drug, sugammadex, that will work as a catalyst to bring patients out of anesthesia-induced sleep. In studies, the drug reverses the effects of muscle relaxants within 4 minutes, unlike another similar drug that takes over 1 hour to take effect. The drug is already approved and used in 50 countries, generating sales of $261 million in 2012. If approved in the U.S., the drug will likely produce sales of over $600 million annually.
The Food and Drug Administration, however, have stalled approval of the drug until Merck conducts further studies to ensure its safety. Merck states that the FDA's decision is based on a concern over whether the drug increases the risk of allergic reactions and bleeding. In 2008, those risks prompted the FDA to decline approval of this drug. The drug was originally manufactured by Organon BioSciences, which was bought by Schering-Plough in 2007. In 2009, Merck acquired the rights to the drug when it bought Schering-Plough. Many physicians were unsure why the FDA refused to approve the drug now 5 years after its initial disapproval, as many other countries use it and studies have shown it to be safe. Of the 5 million surgeries in the U.S. in 2012 that used the specific muscle relaxant/anesthesia designed to be used with sugammadex, 60% involved a reversal agent, indicating a need for an effective and safe drug in this area of medicine.