S-P's sugammadex NDA gets priority status

US drug major Schering-Plough says that the Food and Drug Administration has assigned priority review status to the company's New Drug Application for sugammadex, which the firm acquired along with its purchase of Organon Biosciences last year (Marketletters passim).

Sugammadex is specifically designed to reverse the effects of certain muscle relaxants, marketed in the USA as Zemuron (rocuronium bromide) and vecuronium bromide. Muscle relaxants are used as part of general anesthesia during surgical procedures. If approved, sugammadex will be the first in a new class of drugs known as selective relaxant binding agents that work in an entirely new and unique way to encapsulate the muscle relaxant molecule and render it inactive.

Organon has had a strong presence in the anesthesia market for over 35 years, said Robert Spiegel, chief medical officer and senior vice president, the Schering-Plough Research Institute. "The development of sugammadex is an exciting advance for the practice of anesthesia. This novel drug has the potential to change the way doctors practice anesthesia as it will allow anesthesiologists to rapidly and safely reverse both shallow and profound levels of muscle relaxation, which is not possible with current reversal agents," he noted.