Schering-Plough Corporation's Sugammadex Provides Fast Reversal of Effects of Muscle Relaxants Used in General Anesthesia; Data Presented at European Society of Anesthesiology Show Potential of Novel Investigational Agent to Change Practice of Anesthesiol
COPENHAGEN, Denmark, June 2 /PRNewswire-FirstCall/ -- Schering-Plough today announced that sugammadex, a novel experimental muscle relaxant reversal agent, reversed moderate (shallow) rocuronium- and vecuronium-induced muscle relaxation considerably faster than the current standard of care in reversal agents, according to data presented today at the annual meeting of the European Society of Anesthesiology (ESA), Euroanaesthesia 2008, in Copenhagen, Denmark. Due to the benefits that a faster reversal agent might offer, these results suggest that sugammadex could change the way muscle relaxation is practiced during anesthesia.
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 have limitations with regard to their effectiveness and are associated with undesirable side effects. The availability of a reversal agent that works quickly to reverse the muscle relaxant effects of general anesthesia would potentially offer anesthesiologists a greater level of control.
Results from a pooled analysis of Phase II and III clinical trial data showed that sugammadex reversed the effects of shallow rocuronium-induced muscle relaxation during general anesthesia in just under two minutes (median time to reversal), over nine times faster than neostigmine, and almost 20 times faster than placebo. Findings from another pooled analysis of Phase II and III data show that sugammadex reversed the effects of shallow vecuronium-induced muscle relaxation during general anesthesia in just over two minutes (median time to reversal), about eight times faster than neostigmine, and over 30 times faster than placebo.
"By not using reversal agents, or by using agents that work slowly, patient recovery from surgery is prolonged," said Professor Manfred Blobner from the Klinik fur Anasthesiologie der Technischen Universitat Munchen, Germany. "These data reinforce our belief that sugammadex has the potential to change the way anesthesia is practiced by offering us a tool that appears safe, tolerable and very effective in controlling and quickly reversing the effects of muscle relaxation."
Safety Data
Findings presented reinforce the tolerability of sugammadex as a reversal agent for both rocuronium- and vecuronium-induced muscle relaxation during anesthesia. In a pooled analysis of 640 patients or healthy volunteers given rocuronium or vecuronium, the proportion of patients with more than one adverse event was similar in patients given sugammadex as compared to placebo (68 percent vs. 72 percent, respectively.) Adverse events occurring in at least 2 percent of sugammadex subjects and at least twice as frequently as in placebo subjects included anesthetic complications and cough. Most adverse events were mild to moderate in intensity. In total, 5.8 percent of sugammadex and 4.3 percent of placebo subjects experienced at least one serious adverse event.
About Sugammadex
Sugammadex is a novel selective reversal binding agent (SRBA) under development by Schering-Plough Corporation. Sugammadex is currently under review for marketing approval in the U.S., Europe and Japan.
On May 30, 2008, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) 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). The European Commission is expected to issue its decision regarding sugammadex later this year. Rocuronium and vecuronium are marketed in Europe under the trade names ESMERON(R) and NORCURON(R), respectively. In March 2008, the U.S. Food and Drug Administration Advisory Committee on Anesthetics and Life Support voted unanimously to recommend sugammadex for approval.
If approved, sugammadex will be the first and only reversal agent of a new class, and will offer anesthesiologists the ability to reverse both shallow as well as profound muscle relaxation induced by the commonly used muscle relaxants, rocuronium or vecuronium, within minutes. This will provide 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 quickly breathe on their own again.
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.
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