Merck's investigational drug Bridion (sugammadex), which is used to reverse neuromuscular blockade caused by rocuronium or vecuronium in general anesthetics, has once more been denied approval by the US Food and Drug Administration.
General Anesthetic Effect Drugs Development Market decision after receiving an exhaustive response letter regarding sugammadex's resubmitted new drug application.
In 2008, the FDA initially denied approval for the medication, citing allergic reactions and bleeding in some patients.
Concerns were raised in the latest letter to Merck regarding operational aspects of a 2008 hypersensitivity study that the FDA requested.
"We will work closely with the FDA to bring this product to hospitals, surgeons, anesthesia professionals, and patients in the United States," the company says. "We believe sugammadex is an important innovation."
Merck said it was reading the letter and wanted to figure out a way to move the drug forward "very soon."
As of June 2013, the company reported that more than five million vials of Sugammadex had been sold. The medication is approved for use in fifty countries other than the United States.
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At a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) in July, the FDA decided not to talk about sugammadex because it needed more time to evaluate the results of an inspection it did at a clinical trial site that was doing the hypersensitivity study.
David Michelson, head of global neuroscience clinical development at Merck Research Laboratories, stated: We will collaborate closely with the FDA to bring sugammadex to American hospitals, surgeons, anesthesiologists, and patients. "Sugammadex is an important innovation," we say.
Sugammadex is designed to reverse the state by directly inactivating rocuronium or vecuronium through encapsulation, which is used in anaesthetics to induce muscle relaxation during surgery.