Aetna and Propofol MAC reimbursement

US FDA staff-Proposed Eisai sedative seems to work

WASHINGTON, May 5 - An experimental sedative from Japan's Eisai Co Ltd appeared to be effective in a preliminary evaluation of data, U.S. drug reviewers said in an analysis released on Monday.
The Food and Drug Administration will ask an advisory panel, however, if the drug can be given safely by medical personnel without general anesthesia training, agency staff said. The panel of outside experts meets on Wednesday.
The FDA's review was ongoing but so far data seemed to back the maker's finding that the drug, Aquavan, was safe as used in clinical studies, according to the analysis dated April 11 and posted on the agency's Web site on Monday.
Eisai, Japan's fourth-largest drugmaker, is seeking FDA approval to sell Aquavan for sedation of adults undergoing various medical procedures.
The intravenous drug was tested in patients undergoing colonoscopy, as well as bronchoscopy, a procedure that gives a look at the airways, and various minor surgical procedures.
The generic sedative propofol is commonly used now for colonoscopies but requires the presence of an anesthesiologist.
Aquavan was designed to be less likely to put patients into sudden and unexpected general anesthesia and therefore permit use by more health-care workers, the FDA staff said. General anesthesia poses more risks than mild or moderate sedation.
"A preliminary review of efficacy suggests that (Aquavan) is efficacious as a sedation product," the FDA staff said.
Regarding safety, FDA staff said "the nature and frequency of adverse events, including respiratory adverse events, were limited under the conditions that the studies were conducted."
A key question to the FDA panel is "whether the applicant has presented adequate data to support the safety of the administration of (Aquavan) by persons without training in the administration of general anesthesia, the staff review said.
Mary Lynne Hedley, executive vice president of Eisai Corp of North America, said studies showed "any adverse event that occurs ... can be managed" by non-anesthesiologis ts.
Hedley declined to provide sales estimates for Aquavan. She said the company expects gastroenterologists who perform colonoscopies to be among those most likely to use the drug.
The FDA will consider the advisory panel's input before making a final decision on Aquavan, which is expected by July 26. The agency usually follows panel recommendations.
Eisai gained rights to the drug, known generically as fospropofol, through its recent acquisition of cancer specialist MGI Pharma.
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wow...interesting stuff...what is the upgrade to the sedasys in a few years the "anesys"? I better try to work some more locums before we are all replaced by C3P0 pushing aquavan!