FDA Again Rejects Anesthesia Drug Sugammadex
Agency questions hypersensitivity study (September 23)
The FDA has issued a Complete Response Letter for the resubmission of the New Drug Application for sugammadex sodium injection (Merck), an investigational drug for the reversal of neuromuscular blockade induced by rocuronium or vecuronium.
The FDA’s letter raised concerns about operational aspects of a hypersensitivity study that the agency had requested in 2008.
In July, discussion of sugammadex was cancelled at a meeting of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC). At that time, the FDA advised Merck that the agency needed additional time to assess the results of the agency’s recently completed inspection of a clinical trial site conducting the hypersensitivity study.
Neuromuscular blockade is used in anesthesiology to induce muscle relaxation during surgery. Sugammadex is designed to work by directly inactivating rocuronium or vecuronium, two neuromuscular blocking agents, via encapsulation. If approved, sugammadex would be the first in a new class of medicines, known as selective relaxant binding agents, to be used in the U.S.
Sugammadex is currently marketed in more than 50 countries other than the U.S.
Source: Merck; September 23, 2013.