Organon’s sugammadex has put in an impressive performance in a late-stage trial, working 17 times faster than standard therapy at reversing the neuromuscular blockade necessary for general anaesthesia.
Sugammadex is part of a new class of drugs called selective relaxant binding agents, and has a unique mode of action in that it ‘encapsulates’ two of the most common muscle relaxants used to induce general anaesthesia and renders them inactive, the group explained.
Phase III data from the Signal study, presented at the American Society of Anesthesiologists meeting in San Francisco this week, show that patients given Organon’s novel agent took an average of just three minutes to recover from neuromuscular blockade, compared to 50 minutes with standard therapy.
The findings are important as the faster the effects of a general anaesthetic are overcome, the quicker the patient is able to start breathing on their own accord again, which means less time spent in the operating theatre, the company said.
Filed in Europe
Sugammadex’ global Phase III development programme, which consists of five US and five European trials, completed recruitment in late 2006, and a spokesperson for the company confirmed that a registration dossier has been submitted to European regulators, although she could not comment on when the drug is due to be filed in the USA.
Organon, which is being sold to the USA’s Schering-Plough for 11 billion euros, estimates that the global market for the drug is estimated at 400 million euros.