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Home Industry News Schering-Plough’s sugammadex receives priority review status

Schering-Plough’s sugammadex receives priority review status

3rd January 2008

Schering-Plough has announced that its New Drug Application for sugammadex has been assigned priority review status by the US Food and Drug Administration.

Subject to a positive decision, the pharmaceutical company has confirmed that sugammadex would be the first selective relaxant binding agent to be given regulatory approval.

These agents work in a novel way by encapsulating the muscle relaxant molecule and rendering it inactive.

Sugammadex is specifically designed to reverse the effects of muscle relaxants rocuronium bromide (Zemorun / Esmuron / Eslax) and vecuronium bromide.

Schering-Plough acquired sugammadex as a result of its acquisition of Organon BioSciences in November 2007.

Robert J Spiegel, chief medical officer and senior vice-president of the Schering-Plough Research Institute, illustrated that Organon had a strong presence in the anaesthesia market for over 35 years.

Commenting on sugammadex, he added: “This novel drug has the potential to change the way doctors practice anaesthesia as it will allow anaesthesiologists to rapidly and safely reverse both shallow and profound levels of muscle relaxation, which is not possible with current reversal agents.”

Last month, Schering-Plough reported new study results showing that asenapine was well tolerated in patients and more effective than placebo as a treatment for acute schizophrenia.

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