Akzo Nobel of the Netherlands says that its anaesthesia compound sugammadex, developed by its healthcare unit Organon, has shown great promise in a late-stage trial and is on track to be filed soon.
Data from its pivotal Phase III trial, called Aurora, presented at the Euroanaesthesia 2007 congress in Munich, Germany, revealed that sugammadex, a novel selective relaxant binding agent, demonstrated a nine-12 times faster reversal of neuromuscular blockade as compared to neostigmine, without evidence of post operative residual curarisation or re-occurrence of muscle relaxation.
The Aurora trial compared the efficacy of sugammadex and neostigmine for the reversal of shallow neuromuscular blockade induced by single or multiple doses of either Esmeron/Zemuron (rocuronium) or Norcuron (vecuronium). It was conducted at 13 European centres and enrolled 198 patients and showed that median time to recovery with sugammadex was 1.4 minutes versus 17.6 minutes for neostigmine following rocuronium administration and 2.1 minutes versus 18.9 minutes respectively following vecuronium administration. The most commonly reported adverse events with sugammadex included dry mouth, nausea, vomiting, chills and procedural hypertension.
Organon added that in the clinical trials conducted to date, sugammadex has generally demonstrated the ability to reverse shallow and profound depths of rocuronium-induced neuromuscular blockade within three minutes, “thereby enabling unprecedented control of the onset and offset of skeletal muscle relaxation through the use of both drugs”.
Sugammadex's global Phase III development programme, which consists of five US and five European trials, completed recruitment in late 2006 and the firm said that the submission of the registration files for the USA, Europe and Japan are on schedule. Organon, which is being sold to the USA’s Schering-Plough for 11 billion euros, added that the global market for the drug is estimated at 400 million euros.