Experimental sedative seems to work: US FDA staff

An experimental sedative from Japan’s Eisai Co Ltd appears effective based on a preliminary evaluation of data, U.S. drug reviewers said in an analysis released on Monday.

The Food and Drug Administration staff also said the agency’s review of Aquavan was ongoing but so far “has not produced evidence that contradicts the applicant’s finding of relative safety.”

The staff said, however, that the agency would seek an advisory panel’s input on Wednesday about various issues, including whether the intravenous drug can be given safely by people without general anesthesia training.

Eisai, Japan’s fourth-largest drugmaker, is seeking FDA approval to sell Aquavan for sedation of adults undergoing various medical procedures.

Eisai gained rights to the drug through its recent acquisition of cancer specialist MGI Pharma.

In a separate summary, MGI Pharma said safe use by non-anesthesiologists was demonstrated in studies of patients undergoing colonoscopy, as well as bronchoscopy, a procedure that gives doctors a look at the airways, and a variety of minor surgical procedures.

“With appropriate care in patient selection, dosing, and monitoring, (Aquavan) can be safely administered for use as a sedative/hypnotic agent for diagnostic and therapeutic procedures,” MGI Pharma said.