FDA panel unanimously votes to approve S-P's post-surgery drug sugammadex

US drug major Schering-Plough's sugammadex has been unanimously recommended by a Food and Drug Administration advisory committee, which could make it the first and only selective relaxant binding agent that will allow anesthesiologists to reverse muscle relaxation induced by rocuronium and vecuronium minutes after surgery. The Kenilworth, New Jersey-based firm noted that sugammadex allows flexible dosing of relaxants enabling doctors to maintain optimal block through the end of the procedure.

The agent, which was the star acquisition from S-P's $16.3 billion takeover of Organon BioSciences (Marketletter November 26, 2007), could transform the practice of anesthesia through improved management of muscle relaxation in the millions of surgeries where these two muscle relaxants are used, according to analysts and anesthesiologists alike.

The drug, which rapidly restores muscle function so patients can breathe unassisted, was the subject of the entire April 2007 edition of the journal Anesthesia & Analgesia. "Sugammadex is clearly one of the most exciting drugs to appear in the field of anesthesia in many years," wrote Ronald Miller, an anesthesiologist at the University of California, San Francisco, USA.