Merck & Co says the US Food and Drug Administration has accepted its resubmission of the anaesthesia compound sugammadex, which was rejected by the agency in 2008.
Sugammadex has been developed for the reversal of neuromuscular blockade and is designed to work by inactivating rocuronium or vecuronium, ie reversing the effects of anaesthesia after surgery. If approved, Merck notes that it would be the first in a new class of medicines in the USA known as selective relaxant binding agents to be used in the surgical setting; the treatment was approved in Europe in 2008 where it is marketed as Bridion.
However, the FDA rejected sugammadex in August 2008, just a few months after a unanimous recommendation for approval by one of its advisory committees. The agency requested additional data related to allergic reactions and bleeding events and Merck has now submitted this information.