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.”
Joining Brown in a letter were Sidney Wolfe, M.D., founder and senior adviser of Public Citizen’s Health Research Group; Michael Carome, M.D., director of the group; and Meena Aladdin, Ph.D., a health researcher.
Aladdin testified before the committee, urging denial of the request. She said that the opioid doesn’t offer any unique advantages over other available FDA-approved opioid products for treating acute pain, but poses unique risks of serious harm if it’s misused or abused. The FDA has until Nov. 3 to decide whether to approve it.
Sufentanil has been used as an intravenous agent, approved in 1984, by clinicians only in hospital settings for general anesthesia. It’s also used for epidural injections in women during labor and delivery.
Brown described sufentanil as “a very potent opioid with substantial risks of respiratory depression, diversion, abuse and death. It is so potent that abusers of this intravenous formulation often die when they inject the first dose; I have witnessed this in resuscitating physicians, medical students, technicians and other health care providers, some successfully.”
“All of us strongly urge the FDA to reject this needless and dangerous opioid,” Wolfe said. “It has no truly unique benefits and will only worsen the opioid epidemic in this country.”
In addition, the FDA lacks the ability to enforce safeguards after a medication is marketed, Brown said.
“Once the FDA approves an opioid compound, there are no safeguards as to the population that will be exposed, the post-marketing analysis of prescribing behavior, or the ongoing analysis of the risks of the drug to the general population relative to its benefit to the public health,” he wrote. “I would never consider this product for marketing in the U.S.”
In addition, the committee review process was flawed, Wolfe said. The full Drug Safety and Risk Management Committee should have been at the meeting, the group said in the letter, adding that not including those members increased the odds of a vote for FDA approval.
Update Nov. 3:
The Food and Drug Administration approved sufentanil Friday for use in health-care settings, rejecting criticism from some of its advisers that the drug would inevitably be diverted to illicit use and cause more overdose deaths, according to a Washington post article.
