WELWYN GARDEN CITY, England, November 10 /PRNewswire/ --
- Award-Winning UK Research Leads to First new Category of Drugs in Anaesthesia Medicine in the Last Two Decades
In England alone, an estimated seven million people have NHS operations every year(1) and the majority of these are conducted under general anaesthesia. From today, a new medicine is available in the UK that will enable anaesthetists to reverse the muscle relaxation part of the general anaesthesia process quicker than before,(2),(3),(4),(5),(6) potentially meaning advantages for busy operating lists.(8) BRIDION(R) (sugammadex) injection, the first medicine in a new category of drugs called Selective Relaxant Binding Agents (SRBAs),(2),(6) has been launched by Schering-Plough following extensive research and development in the UK and represents the first new class of anaesthesia medicine in the last two decades.
Anaesthesia allows patients to undergo surgery and other procedures without the distress and pain that could otherwise be experienced. General anaesthesia is the most common form of anaesthesia and is used to provide surgeons with the best conditions for a given operation or procedure. Modern, general anaesthesia places the patient in a state of controlled unconsciousness and also provides pain relief (analgesia). For a number of types of surgery, an anaesthetist will also induce muscle relaxation using a neuromuscular blocking agent (NMBA) in order to prevent patient movement and to make it easier to insert a breathing tube if needed for mechanical ventilation.(7) Sugammadex has been specifically designed to render inactive two commonly used NMBAs (rocuronium and vecuronium, known as non-depolarising NMBAs), rapidly reversing their muscle relaxing effects during an appropriate point in an operation.(2),(4)
Explaining the importance of this development in anaesthesia medicine, Dr Iain Moppett, Associate Professor and Honorary Consultant, Nottingham University NHS Trust, who was involved in the sugammadex clinical trials, comments, Along with inducing controlled unconsciousness and providing pain relief, muscle relaxation is important in many types of surgery, including brain, cardiothoracic, abdominal and eye surgery. Once surgery has been completed we need to fully reverse the induced muscle relaxation to ensure that distressing, though rare complications, such as difficulty in breathing once the breathing tube has been removed, are avoided.
Sugammadex is a modified gamma-cyclodextrin molecule, which is in essence a ring of sugar molecules that form a doughnut shape with a hole in the middle. Its ability to reverse the effects of NMBAs was discovered during a 'eureka' moment when a team of Scottish-based Schering-Plough researchers were investigating how to dissolve rocuronium in the laboratory. It was discovered that gamma-cyclodextrin has a structure that allows it to encapsulate rocuronium and vecuronium by trapping these NMBA molecules in the hole at the centre of the molecule, forming a new, inactive complex which can then be excreted from the body. Following the discovery, the Schering-Plough team refined the cyclodextrin structure to make it as effective as possible and created the sugammadex molecule. The research was awarded the prestigious Royal Society of Chemistry's Malcolm Campbell Memorial prize in June 2007.(9)
Sugammadex was licensed for use by the European Medicines Agency (EMEA) on 29 July 2008. It is indicated for routine reversal of the NMBAs rocuronium or vecuronium (both marketed by Schering-Plough in the UK) and for immediate reversal of rocuronium in adults, and for routine reversal of rocuronium in children and adolescents (2-17 years of age). Sugammadex is generally well tolerated and is only contraindicated in patients who are hypersensitive to the agent itself.(2),(10)
Current practice in reversal of non-depolarising NMBAs
The muscle relaxing action of non-depolarising NMBAs (rocuronium, vecuronium, atracurium) usually needs to be reversed at an appropriate point. Up until now, this has been achieved with anticholinesterase drugs. In the UK, neostigmine is the most commonly used.
Schering-Plough is an innovation-driven, science-centred global health care company. Through its own biopharmaceutical research and collaboration 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., and its Web site is http://www.schering-plough.com
Schering-Plough UK is a country operation of Schering-Plough and its Web site is http://www.schering-plough.co.uk/spuk/index.jsp
Date of preparation: November 2008 SUG/08-011
1. HES online (Hospital Episode Statistics) http://www.hesline.nhs.uk (last accessed 17.09.08)
2. BRIDION(R) SmPC.
3. Blobner M, et al. Sugammadex (2.0 mg/kg) significantly faster reverses shallow rocuronium-induced neuromuscular blockade compared with neostigmine (50 mcg/kg). Eur J Anaesthesiol 2007;24(Suppl 39):125.
4. Bom A, et al. A novel concept of reversing neuromuscular block: chemical encapsulation of rocuronium bromide by a cyclodextrin-based synthetic host. Angew Chem Int Ed Engl 2002;41:266-70.
5. Jones RK, et al. Faster reversal of profound rocuronium-induced neuromuscular blockade with sugammadex vs. neostigmine. Anaesthsiol 2007;107:A1577.
6. Suy K, et al. Effective reversal of moderate rocuronium- or vecuronium-induced neuromuscular block with sugammadex, a selective relaxant binding agent. Anesthesiol 2007;106:283-288.
7. Royal College of Anaesthetists, anaesthesia explained, 2nd edition, January 2003, http://www.rcoa.ac.uk/docs/PI_ae.doc (last accessed 25.07.08).
8. Flockton EA, et al. Reversal of rocuronium-induced neuromuscular block with sugammadex is faster than reversal of cisatracurium-induced block with neostigmine. BJA, May;100(5):622-30.
9. Royal Society of Chemistry, Press Release, June 2007 (Royal Society of Chemistry, June 2007, http://www.rsc.org/AboutUs/News/PressReleases/2007/OrganonAward.asp (last accessed 25.09.08).
10. McDonagh DL, et al. Efficacy and safety of sugammadex for reversal of rocuronium-induced neuromuscular blockade in adults and elderly patients. Anesthesiol 2007;107:A1583.
For further background information on sugammadex, muscle relaxation and reversal, please contact: Jim Baxter, Schering-Plough, on: tel: +44(0)1707-363-990, email: firstname.lastname@example.org OR Sarah Hoffman or Aaron Pond, Aurora, on: tel: +44(0)-20-7424-7940, email: email@example.com, firstname.lastname@example.org