The quest for FDA approval of sugammadex, Merck's anesthesia-reversal drug, has hit yet another delay.

Merck announced in a press release yesterday that the agency has cancelled an advisory committee review scheduled for later this week. The FDA, says Merck, wants more time to assess the results of a recently completed clinical trials site — one of 4 sites that conducted a hypersensitivity study requested by the FDA.

The FDA first rejected Sugammadex, which is marketed in 40 other countries as Bridion, in 2008 because of concerns about allergic reactions and increased risks of bleeding when used concomitantly with blood-thinning drugs.

Merck, which acquired the drug in 2009, when it merged with Schering-Plough, has conducted additional studies since then. This past March, however, the FDA again refused to approve the drug, asking for another 3 months to complete its review.

The drug reverses the muscle-relaxing effects of rocuronium and vecuronium.

Jim Burger