A U.S. Food and Drug Administration advisory committee has recommended approval of AcelRx Pharmaceuticals’ application for use of sufentanil sublingual tablets to treat moderate-to-severe acute pain in a medically supervised setting. It’s five to 10 times more potent than fentanyl and 1,000 times more potent than morphine. The committee voted 10-3 last week for the medication to be approved.
However, Raeford Brown, M.D., chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee that made the recommendation, joined three Public Citizen staff in urging the agency to reject the application. Public Citizen is a consumer advocacy organization.
“I predict that we will encounter diversion, abuse and death within the early months of its availability on the market,” Brown said, adding strong opioids often are abused by medical personnel. “Sublingual sufentanil represents a danger to the general public health and will make our job of protecting Americans more difficult.”