This is a big boost for the beleaguered drugmaker. An FDA advisory committee voted unanimously to recommend Bridion for reversing the effects of certain muscle relaxants and helping patients recover more quickly from anesthesia after procedures, although the endorsement came with some caveats - post-marketing studies should address an allergic reaction marked at times by rash and flushing, and electrical disturbances in the heart.

“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, Reuters reports.

For instance, 33 patients in the Bridion group at one dose had a heart safety issue, versus three patients in a group getting an older generic. These events included slow and fast heartbeats, and heart fluttering, among others. None of the hypersensitivity reactions rose to the level of “serious,” but there were some signals that anaphylactic reactions - more severe allergic responses - were possible, FDA reviewers said.

Another issue is cost. The drugmaker presented data showing its med cut the time it took patients to recover from anesthesia by 10 percent to 20 percent, but price may be an issue. Mike Krensavage, an analyst at Raymond James, speculated Bridion could cost up to $100, compared to “just a few dollars” for standard drugs now used to reverse the effects of muscle relaxants. “If hospitals are willing to pay for it, it will be widely used because of its safety and convenience, perhaps by 25 percent of eligible patients,” he told Reuters.

“Assuming Schering-Plough charges a reasonable price for Bridion in this market (approximately $15 to $20 a dose), the drug should be widely used and generate significant revenues,” wrote Credit Suisse analyst Catherine Arnold, in an investor note. She expects the FDA to approve Bridion and forecasts $520 million worldwide revenue in 2012.

Bridion also needs further testing for its impact in children and the effect on the bones, and shouldn’t be recommended for kidney patients because the drug took a much longer time to clear from the body in this group, Reuters adds. 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 their medical toolbox, according to panel chairman John Farrar, an epidemiologist and statistician at the University of Pennsylvania.