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12:00 AM
 | 
May 12, 2008
 |  BioCentury  |  Regulation

It's all about the middleman

Regulation

It's all about the middleman

Eisai Co. Ltd. had hoped Aquavan fospropofol would prove safe enough for use by non-anesthesiologists in outpatient diagnostic and therapeutic procedures. But an FDA panel made clear its discomfort with that idea last week, meaning Aquavan could end up with a label that gives it no edge over propofol, which several payers have decided not to cover because of the cost associated with the need for an anesthesiologist.

By an 8-2 margin, FDA's Anesthetic and Life Support Drugs Advisory Committee made clear that it was not convinced Aquavan could be used safely by non-anesthesiologists. The panel did, however, agree with the company's assessment that Aquavan is an effective sedative and voted 6-3 with one abstention that it deserves approval.

According to Mary Lynne Hedley, EVP at Eisai Corp. in North America, there is a gap in the outpatient setting for patients in need of an anesthetic prior to undergoing a routine diagnostic or therapeutic procedure. This is a large and growing market that includes an estimated 16 million colonoscopies performed last year in the U.S. alone.

On one side of the gap are the benzodiazepines, which are relatively safe and can be administered by the doctor performing a procedure but are only moderately effective.

On the other side is propofol, which has a hypnotic effect that most patients prefer over the benzodiazepine "experience," but has a steep dose response curve and is ultimately much more expensive because it must be administered by a trained anesthesiologist.

Eisai thought it had found a middle ground in Aquavan, a water-soluble prodrug of propofol that it picked up through its acquisition of MGI Pharma Inc. (see BioCentury, Dec. 17, 2007).

The company believes that as a pharmacologically inactive prodrug of propofol, Aquavan will be safer because the active moiety is liberated gradually by phosphatase enzymes once inside the body, producing a smoother increase and decrease in plasma concentrations of the agent and a lower Cmax.

Propofol's label requires that it be used in the context of monitored anesthesia care (MAC),...

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