Merck: FDA Cancels Meeting On Wake-Up-After-Surgery Drug
Drugmaker Merck & Co. Inc. said Tuesday that the Food and Drug Administration has cancelled a Thursday meeting to review its drug designed to help patients "wake up" after surgery with anesthesia.
The company said in a statement that the FDA wants more time to assess the drug, called sugammadex, following an agency inspection of one of the company's clinical trial sites. The site was one of four where Merck was studying allergic reactions to the drug.
The announcement is the latest in a series of regulatory setbacks for the experimental drug, which was previously rejected by the FDA in 2008 due to allergic reactions and bleeding among some patients. Then in March this year the FDA notified the company that it would need another three months to review the data on sugammadex.
The injectable drug, if approved, would be the first in a new class of medicines in the U.S. for reversing effects of certain muscle-relaxing drugs given along with anesthesia during surgery.
Sugammadex was approved in 2009 in European Union countries.
Merck said in a statement it would "work with the FDA on the next steps to bring" the drug to the U.S. market.