Fospropofol disodium injection, an intravenous sedative-hypnotic agent for sedation in adults undergoing diagnostic or therapeutic procedures, is closer to an FDA OK after the agency's Advisory Committee on Anesthetic and Life Support Drugs voted 6 to 3 (with one abstention) in favor of approval, recommending that the drug be used only by appropriately trained healthcare providers. The committee also recommended additional studies be conducted in specific patient populations, including those with a variety of comorbidities, those weighing less than 60 kg and the elderly.

Made by Eisai Corporation of North America and its U.S. subsidiary, MGI Pharma, fospropofol disodium injection is a proprietary water-soluble prodrug of propofol that, after intravenous injection, is converted by an enzymein the body into propofol. FDA reviewers are scheduled to make a decision about final approval on July 26; they are not bound by the advisory committee's recommendations, but generally follow its advice.

Data from one Phase II and one Phase III trial in patients undergoing colonoscopy, a Phase III trial in patients undergoing bronchoscopy, and an open-label study in patients undergoing a variety of minor surgical procedures form the foundation of the fospropofol disodium injection NDA. In total, data from 21 clinical studies involving 1,611 individuals are included in the application. The clinical trials were conducted by non-anesthesia health care professionals, and study drugs were administered by medical personnel as dictated by local investigative site guidelines.

Among the draft discussion points the advisory committee focused on were how practitioners can reasonably determine depth of sedation to determine supplemental dosing, and whether fospropofol disodium injection can be safely managed by providers without training in general anesthesia.

According to a report in the Wall Street Journal, during the public comment period of the committee's meeting, several doctors said that "the sedative would fill a 'gap' in hospitals and clinical offices that don't have enough people trained in general anesthesia."

"We are encouraged by ALSDAC's support of the efficacy and safety results of fospropofol disodium demonstrated in our clinical studies, and we look forward to continuing our discussions with FDA as they finalize their review of our application," says Mary Lynne Hedley, PhD, executive vice president of Eisai Corporation of North America, in a statement. "We believe the clinical trial data support the use of this product by anesthesiologists and nonanesthesia health care professionals."