March 14, 2008 – Schering-Plough this week said the 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 FDA is not bound by the committee’s recommendations, however, its recommendations are usually considered carefully before a final decision on approval is made.
Upon FDA approval, sugammadex will be the first 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.
Earlier this year, Schering-Plough announced the FDA assigned priority review status to the company’s new drug application (NDA) for sugammadex. In the U.S., priority review is granted to drugs the FDA believes will provide meaningful benefit over existing treatment options.
The company says Sugammadex is specifically designed to reverse the effects of certain widely used muscle relaxants, marketed in the U.S., such as ZEMURON (rocuronium bromide) and vecuronium bromide. Muscle relaxants are used as part of general anesthesia during surgical procedures. Sugammadex works to encapsulate the muscle relaxant molecule and restore muscle function so patients can breathe on their own again. Reversal with sugammadex is generally rapid and can be used in emergency situations when immediate reversal of rocuronium is needed.
Schering-Plough acquired sugammadex through its combination with Organon BioSciences in November 2007.
Sugammadex is a novel selective relaxant-binding agent (SRBA) under development by Organon, a part of Schering-Plough Corp. Sugammadex was designed to reverse the effects of rocuronium bromide or vecuronium bromide (ZEMURON, ESMERON, ESLAX), muscle relaxants commonly used during surgeries that require profound muscle relaxation. Anesthesiologists use muscle relaxation to improve surgical conditions, to facilitate intubation and mechanical ventilation and to reduce the chance of complications.
In clinical trials to date, sugammadex has demonstrated the ability to rapidly reverse shallow and profound depths of rocuronium-induced muscle relaxation, thereby enabling control of the onset and offset of skeletal muscle relaxation through the use of both drugs. Sugammadex also has demonstrated the ability to reverse the effects of muscle relaxation induced by vecuronium bromide. The most common adverse reactions (incidence >5%) seen with sugammadex in clinical trials were anesthetic complications generally due to restoration of muscle function (8 percent) and dysgeusia (12.6 percent).
ZEMURON (rocuronium bromide) is a non-depolarizing muscle relaxant. It was introduced in the U.S. in 1994 and is one of the most widely used muscle relaxants in the U.S., Canada and many European countries. To date, it has been used in over 140 million patients worldwide, including an estimated 20 million patients in 2006.