KENILWORTH, N.J., June 2 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP - News) today reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended approval of sugammadex for routine reversal of the muscle relaxants rocuronium or vecuronium and for immediate reversal of rocuronium in adults, and for routine reversal following rocuronium in children and adolescents (2-17 years of age). Rocuronium and vecuronium are marketed in Europe under the trade names ESMERON® and NORCURON®, respectively.
The CHMP recommendation serves as the basis for a European Commission approval of this novel medicine. Upon European approval, sugammadex will be the first and only selective relaxant binding agent (SRBA) and will enable anesthesiologists to rapidly and predictably reverse both moderate and deep muscle relaxation induced by rocuronium and vecuronium. Sugammadex creates the opportunity for anesthesiologists to maintain optimal muscle relaxation to the end of a surgical procedure and to reverse the block in minutes.
“This is an important first step in realizing the promise of our Organon BioSciences acquisition,” said Fred Hassan, chairman and CEO of Schering- Plough. “This was a relatively unknown asset before our acquisition announcement last March, and we are pleased we saw this opportunity.”
“This product has the potential to modernize the use of anesthesia around the world,” added Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute.
Muscle relaxants play several critical roles in general anesthesia: facilitating intubation (the insertion of a tube to assist a patient with breathing during surgery); improving surgical conditions; and reducing the risk of complications during surgery. Reversal agents are given to stop the effects of muscle relaxants, allowing patients to breathe on their own again. Current reversal agents are slow and associated with undesirable side effects. Sugammadex will allow anesthesiologists to optimize the use of muscle relaxants.
“The data in the clinical trials demonstrate that sugammadex will give anesthesiologists greater control over muscle relaxation, in a way that has never been available to us before,” said Professor Rajinder Mirakhur, Professor of Anaesthetics at The Queen’s University of Belfast, Northern Ireland, a principal investigator in the sugammadex clinical trials program. “The drug allows us to reverse the effects of rocuronium quickly and at the moment that we want during a surgical procedure.”
The CHMP positive opinion is based on a comprehensive clinical trial program including the results from the SIGNAL and AURORA clinical trials.
The SIGNAL trial involved adult patients undergoing surgery. Rocuronium was administered, at a standard dose, to allow intubation, followed by maintenance doses as required. When 1-2 post-tetanic counts (PTC) were observed following neuromuscular stimulation (deep block), patients were administered either sugammadex or neostigmine plus glycopyrrolate, the current standard of care in reversal. SIGNAL clinical findings demonstrate that the median times to reversal of muscle relaxation to a train-of-four (TOF) ratio of 0.9 occurred in 2.7 minutes in the sugammadex group and 49.0 minutes in the neostigmine/glycopyrrolate group.
The AURORA trial involved adult patients undergoing surgery. Rocuronium was administered, at a standard dose, to allow intubation, followed by maintenance doses as required. At the re-appearance of the second twitch (T2) in a TOF stimulation (moderate block) patients were administered either sugammadex or neostigmine plus glycopyrrolate, the current standard of care in reversal. AURORA clinical findings demonstrate that the median times to reversal of muscle relaxation to a TOF ratio of 0.9 occurred in 1.4 minutes in the sugammadex group, and in 17.6 minutes in the neostigmine/glycopyrrolate group.
About sugammadex
Sugammadex is a novel selective reversal binding agent (SRBA) under development by Schering-Plough Corporation. It will offer anesthesiologists the ability to reverse both moderate as well as deep muscle relaxation induced by the commonly used muscle relaxants ZEMURON/ESMERON®/ESLAX® (rocuronium bromide) or NORCURON®/MUSCULAX® (vecuronium bromide), within minutes, enabling greater control over muscle relaxation during and after surgery. Sugammadex works in an entirely novel way to encapsulate the muscle relaxant molecule and restore muscle function so that patients can breathe quickly on their own again.
In clinical trials to date, sugammadex has demonstrated the ability to rapidly reverse moderate and deep depths of rocuronium-induced muscle relaxation, thereby enabling control of the onset and offset of skeletal muscle relaxation through the use of both drugs (1). Sugammadex also has demonstrated the ability to reverse the effects of muscle relaxation induced by vecuronium bromide. 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 with sugammadex) and dysgeusia (impairment of the sense of taste) (12.6 percent).
Schering-Plough acquired sugammadex through its combination with Organon BioSciences on November 19, 2007. Sugammadex is currently under review for marketing approval in the U.S., Europe and Japan. In March 2008, the U.S. Food and Drug Administration Advisory Committee on Anesthetics and Life Support voted unanimously to recommend sugammadex for approval.
About ESMERON
ESMERON (rocuronium bromide) is a non-depolarizing muscle relaxant. It was introduced in Europe 1994 and is one of the most widely used muscle relaxants in the United States, Canada (where it is marketed under the brand name ZEMURON) and many European countries. It was approved for use in Japan on July 31, 2007, under the brand name ESLAX.
About Schering-Plough
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. In November 2007, Schering-Plough acquired Organon BioSciences, with its Organon human health and Intervet animal health businesses, marking a pivotal step in the company’s ongoing transformation. Schering-Plough’s vision is to “Earn Trust, Every Day” with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the plans for, the potential of and the potential market for sugammadex. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough’s forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering- Plough’s Securities and Exchange Commission filings, including Part I, Item IA. “Risk Factors” in Schering-Plough’s 2008 Q1 10-Q.
Reference: (1) Jones K et al. Faster Reversal of Profound Rocuronium-Induced Neuromuscular Blockade with Sugammadex vs. Neostigmine. Anesthesiology 2007; 107: A1577.
Source: Schering-Plough Corporation
