Panel backs Schering-Plough's Bridion

FDA's Anesthetic and Life Support Drugs Advisory Committee voted unanimously (10-0) that Schering-Plough (NYSE:SGP) provided enough data from its three pivotal Phase III studies to support the use of Bridion sugammadex for the routine reversal of shallow and profound neuromuscular blockade induced by muscle relaxants rocuronium or vecuronium. The panel also unanimously supported the use of Bridion for the immediate reversal of neuromuscular blockade at three minutes after administration of rocuronium, although an official vote was not taken.

Before voting, the panel discussed agency concerns, including the clinical relevance of the primary endpoint for demonstrating the superiority of Bridion over succinylcholine in the immediate reversal of neuromuscular blockade. Panel members agreed that a clinically relevant endpoint could not be studied ethically, and that a trial replicating a "cannot ventilate/cannot intubate" scenario is impossible (See BioCentury Extra, Friday, March 07, 2008). ...