Schering-Plough says that regulators in the USA will give a priority review to sugammadex, its new drug which is designed to reverse the effects of certain muscle relaxants used in general anaesthesia during surgery.

The US Food and Drug Administration has assigned priority review status to the company's New Drug Application for sugammadex, which means that the agency will decide whether to approve the treatment within six months, rather than the customary 10-12 month review period. Sugammadex, which S-P got hold of through its recent acquisition of Organon BioSciences from Akzo Nobel, reverses the effects of certain muscle relaxants, such as Zemuron/Esmeron/Eslax (rocuronium bromide) and vecuronium bromide.

If approved, sugammadex will be the first in a new class of drugs known as selective relaxant binding agents that work in what S-P describes as “an entirely new and unique way to encapsulate the muscle relaxant molecule and render it inactive”.

Robert Spiegel, chief medical officer at the Schering-Plough Research Institute, said that Organon has had a strong presence in the anaesthesia market for over 35 years and “the development of sugammadex is an exciting advance” in that field. He added that the drug “has the potential to change the way doctors practice anaesthesia” as it will “rapidly and safely reverse both shallow and profound levels of muscle relaxation”, which is not possible with current treatments.

In a Phase III trial, the most frequently reported adverse events associated with sugammadex “regardless of relationship to the study drug” were procedural pain and nausea, S-P concluded.