Schering anesthesia drug effective: US FDA panel

A Schering-Plough Corp drug aimed at reversing the effects of anesthesia appears effective, but it may not always be a better choice than existing therapies, U.S. regulatory advisers said on Tuesday.

A Food and Drug Administration expert panel is weighing the risks and benefits of the drug, to be called Bridion, and known generically as sugammadex. The drug aims to reverse the effects of certain muscle relaxants and help patients recover more quickly from anesthesia after medical procedures.

“To me it seems yet another alternative,” not a major breakthrough, said Julia Pollock, an anesthesiologist, assistant professor at the University of Washington Medical Center and a panel member.

The FDA advisory panel was asked if the drug provided a “clear advantage” over existing therapies.

Instead, most panel members said it was effective and could be a useful addition to the medical toolbox, according to panel chairman John Farrar, an epidemiologist and statistician at the University of Pennsylvania. The group was expected to later discuss the safety of Bridion.

Bob Rappaport, director of the FDA’s division of anesthesia, analgesia and rheumatology drugs, told the panel that data received in the last two weeks by the FDA raised “concerns” about the drug’s safety.

A Schering-Plough official told the panel that only one patient suffered from so-called hypersensitivity - an allergic reaction marked at times by rash, flushing and heart disturbances. That case was mild and resolved itself, said Patrick Boen, a senior medical director at Schering-Plough’s anesthesia unit.

FDA staff cited eight cases of hypersensitivity, though an agency reviewer noted that only three cases may be related to the drug itself based on the timing of the reaction.

The “safety review is ongoing,” and issues to be resolved include the hypersensitivity reactions and abnormal electrical activity in the heartbeat, FDA staff said in review documents.

None of the hypersensitivity reactions rose to the level of “serious”, but the link between the drug and heart-related side effects cannot be ruled out, the FDA said.

Schering-Plough shares were up 13 cents, or 0.7 percent, to $19.78 in afternoon trade on the New York Stock Exchange.