Eisai Corp. of North America gained FDA approval of the drug Lusedra (fospropofol disodium) Injection, an intravenous sedative-hypnotic agent for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures. Lusedra, perhaps better known by its former name Aquavan, is a prodrug of the generic anesthetic propofol.

In the approval, the FDA required that Lusedra be used only by persons trained in the administration of general anesthesia and that all patients should be continuously monitored by persons not involved in the conduct of the diagnostic or therapeutic procedure. The company had sought to get the drug approved for use by persons not trained in the administration of general anesthesia. But many argued that those who administer the drug should be qualified to rescue patients. In May, eight members of a 10-person task force voted no when asked if a healthcare provider without training in general anesthesia could safely manage fospropofol.

Lusedra is a proprietary water-soluble prodrug of propofol that, after intravenous injection, is converted by alkaline phosphatase enzymes in the body into propofol. Lusedra takes about eight minutes to peak compared to one to two minutes for propofol. The most common adverse reactions (reported in more than 20 percent of patients) are paresthesia and pruritis.

—Dan O???Connor