More FDA review for Merck post-anesthesia drug

Posted: March 17, 2013

Merck & Co. said Friday that a drug designed to help patients coming out of anesthesia after surgery will require three more months of review by the U.S. Food and Drug Administration.

Sugammadex sodium is an injectable drug that reverses the muscle-relaxing effects of anesthesia. If approved, the drug would be the first in a new class of medicine in this country.

Merck is based in Whitehouse Station, N.J., but has a big operation in West Point, Montgomery County.

The European Medicines Agency approved the drug in 2008 and it is sold in Europe under the name Bridion.

Merck's revenue from sales of Bridion outside the United States increased in each of the last three years, from $103 million in 2010 to $261 million in 2012, according to the company's 2012 annual report filed with the Securities and Exchange Commission.

The drug was submitted for FDA approval in 2008 by Schering-Plough, which Merck bought in 2009. The FDA rejected the initial application to sell the drug in the United States, citing concerns about allergic reactions and excessive bleeding in some patients during surgery.

As requested, Merck submitted new data to the FDA and said in January that the FDA would review the application again.

"We are pleased the FDA has accepted our resubmission of sugammadex sodium injection for review, as this was a key milestone in our effort to bring this medicine to the U.S.," Darryle D. Schoepp, a senior vice president with Merck Research Laboratories, said in a January statement. "Sugammadex sodium injection is an example of Merck's ongoing commitment to developing new medicines for patients in hospital-based settings."

Merck said Friday it hoped this next phase of review would be completed in the second half of 2013.

Contact David Sell at dsell@ or 215-854-4506. Read his blog at phillypharma and on Twitter @phillypharma.

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