July 29, 2008
BRIDION(R) (Sugammadex) Injection – First and Only Selective Relaxant Binding Agent – Approved in European Union
KENILWORTH, N.J., July 29 /PRNewswire-FirstCall/ -- Schering-Plough Corporation today announced that the European Commission (EC) has approved BRIDION(R) (sugammadex) injection, the first and only selective relaxant binding agent (SRBA) and the first major pharmaceutical advance in the field of anesthesia in two decades. BRIDION is indicated for routine reversal of the commonly used 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 given as part of general anesthesia to relax a patient's muscles during surgery, and are marketed in Europe under the trade names ESMERON(R) and NORCURON(R), respectively.
BRIDION works in an entirely novel way by encapsulating the muscle relaxant molecule and rendering it inactive. It was specifically designed to reverse within minutes both moderate and deep muscle relaxation induced by rocuronium or vecuronium during general anesthesia. As a result, BRIDION can give anesthesiologists greater control in managing the depth of muscle relaxation through to the end of a surgical procedure. This may help improve surgical conditions in the millions of procedures where these agents are used.
"This approval of BRIDION represents the first advance in two decades for anesthesiologists and their patients, and has the potential to transform the practice of anesthesia," said Thomas P. Koestler, Ph.D., executive vice president and president of Schering-Plough Research Institute. "This is the first major approval of a product from our combination with Organon BioSciences and is a significant achievement for Schering-Plough. This further validates the value of our combination, which closed in November 2007, and is already making a positive contribution to our business."
BRIDION has a rapid onset and, in addition to routine reversal, can be used in critical situations when immediate reversal of rocuronium is needed. In BRIDION clinical studies, the median time to reversal of rocuronium was about three minutes.
A muscle relaxant plays several critical roles in general anesthesia. Anesthesiologists use muscle relaxation to improve surgical conditions and to facilitate intubation and mechanical ventilation. Reversal agents reverse the effects of muscle relaxants, enabling patients to regain normal muscle function sooner and breathe on their own. Current reversal agents are slow and are associated with certain undesirable side effects, including cardiac rhythm disturbances and gastrointestinal and pulmonary side effects.
"The ability to rapidly reverse both moderate and deep levels of muscle relaxation during general anesthesia was not possible before BRIDION," said Rajinder Mirakhur, M.D., professor of anesthetics at The Queen's University of Belfast, Northern Ireland, and a principal investigator in the BRIDION clinical trials program. "BRIDION can provide us with greater flexibility to induce and maintain the level of muscle relaxation with rocuronium or vecuronium necessary throughout surgery and reverse that relaxation quickly when needed."
BRIDION (sugammadex) Clinical Trials
The EC approval of BRIDION is based on an extensive clinical trial database of approximately 1,800 patients and volunteers, including data from the SIGNAL, AURORA and SPECTRUM 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, a current reversal regimen. In the SIGNAL trial, the median time to reversal of muscle relaxation to a train-of-four (TOF) ratio of 0.9 occurred in 2.7 minutes in the sugammadex group compared to 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 reappearance of the second twitch (T2) in a TOF stimulation (moderate block) patients were administered either sugammadex or neostigmine plus glycopyrrolate. In the AURORA trial, the median time to reversal of muscle relaxation to a TOF ratio of 0.9 occurred in 1.4 minutes in the sugammadex group compared to 17.6 minutes in the neostigmine/glycopyrrolate group.
The SPECTRUM trial was conducted in adult patients undergoing surgery to study the immediate reversal of muscle relaxation. Patients were randomized to receive either rocuronium plus sugammadex or the rapid-onset, short- duration muscle relaxant succinylcholine. The trial demonstrated that rocuronium followed by sugammadex is an effective alternative to succinylcholine.
The EC approval of BRIDION follows a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) that was received in May of this year.
About BRIDION (sugammadex)
BRIDION, the first and only selective relaxant binding agent (SRBA), is the first major pharmaceutical advance in the field of anesthesia in two decades. It was specifically designed to rapidly reverse both moderate and deep muscle relaxation induced by the commonly used muscle relaxants rocuronium bromide (ZEMURON(R)/ESMERON/ESLAX(R)) or vecuronium bromide (NORCURON/MUSCULAX(R)), which can give anesthesiologists greater control over muscle relaxation during surgery. Anesthesiologists use muscle relaxation to improve surgical conditions and to facilitate intubation and mechanical ventilation. BRIDION works in an entirely novel way by encapsulating the muscle relaxant molecule and rendering it inactive, allowing patients to more rapidly regain muscle function after surgery and breathe on their own.
BRIDION is approved in the European Union (EU) for reversal of neuromuscular blockade induced by rocuronium or vecuronium. In children and adolescents, BRIDION is only recommended for routine reversal of rocuronium induced blockade.
In the United States, a New Drug Application (NDA) for sugammadex has been filed with the U.S. Food and Drug Administration (FDA) and assigned priority review status. The FDA Advisory Committee on Anesthetics and Life Support in March of this year unanimously recommended approval of sugammadex. In Japan, a New Drug Application seeking marketing approval of sugammadex has been filed with the Japanese Ministry of Health, Labour and Welfare (MHLW) and is currently under review.
Schering-Plough acquired BRIDION (sugammadex) through its combination with Organon BioSciences in November 2007.
Important Safety Information About BRIDION
BRIDION (sugammadex) should only be administered by or under the supervision of an anesthesiologist. The use of an appropriate neuromuscular monitoring technique is recommended to monitor the recovery of neuromuscular blockade. The use of sugammadex in patients with severe renal impairment is not recommended.
In clinical trials, the most commonly reported adverse reaction was metal or bitter taste. Also commonly reported were anesthetic complications, indicative of the restoration of neuromuscular function, including movement of a limb or the body or coughing during the anesthetic procedure or during surgery, grimacing, or suckling on the endotracheal tube. In a few individuals, allergic-like reactions (i.e. flushing, erythematous rash) following sugammadex were reported.
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 in July 2007 under the brand name ESLAX.
For full Prescribing Information please go to http://www.esmeron.com/. 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. 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., USA, and its Web site is http://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 BRIDION. 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 of these and other risks and uncertainties that may impact forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Item 1A, "Risk Factors" in the company's first quarter 2008 10-Q.
CONTACT: Media, Robert J. Consalvo, +1-908-298-7409, or Investors, JanetBarth, or Joe Romanelli, +1-908-298-7436, both for Schering-Plough
Web site: http://www.schering-plough.com/http://www.esmeron.com/
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