Schering anesthesia drug seems safe-US FDA staff

WASHINGTON, March 7 (Reuters) - A Schering-Plough Corp (SGP.N: Quote, Profile, Research) drug to reverse the effects of anesthesia appears to be safe, U.S. regulatory staff said, but they questioned how the company defined effectiveness in a key study.

Regulators are also still awaiting data on a rare occurrence of hypersensitivity reactions to the drug, Food and Drug Administration staff wrote in documents posted on FDA's Web site on Friday.

"In summary, the Applicant appears to have made a thorough assessment of the safety of Bridion in a relatively healthy adult population, and with the possible exception of hypersensitivity, found the drug product to be safe compared" with current agents, the FDA staff said.

The review comes ahead of an advisory panel next week to consider the risks and benefits of the drug, known generically as sugammadex.

The drug seeks to reverse the muscular blocking effects of certain muscle relaxants, to help patients recover more quickly from anesthesia after medical procedures.

The FDA typically takes the advice of its advisory panels. (Reporting by Kim Dixon, editing by Dave Zimmerman)