Committee Recommends FDA Approve Novel Anesthesia Drug to Reverse Muscle relaxation within Minutes

Schering-Plough  announced today  that the U.S. Food and Drug Administration (FDA) Advisory Committee on Anesthetics and Life Support has recommended sugammadex for approval. After reviewing data on the safety and efficacy of the medication, the committee unanimously recommended approval of the company's application for marketing.

Upon FDA approval, sugammadex will be the first and only selective relaxant binding agent (SRBA) and will give anesthesiologists the ability to rapidly and predictably reverse any depth of muscle relaxation induced by rocuronium and vecuronium within minutes. Sugammadex allows for flexible dosing of muscle relaxation agents enabling anesthesiologists to maintain optimal block through the end of the procedure.

Sugammadex is specifically designed to reverse the effects of certain widely used muscle relaxants, marketed in the United States as ZEMURON(R) (rocuronium bromide) and vecuronium bromide. Muscle relaxants are used as part of general anesthesia during surgical procedures. Sugammadex 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. Reversal with sugammadex is generally rapid and can even be used in emergency situations when immediate reversal of rocuronium is needed.