The FDA approved a powerful new opioid on November 2, 2018, disregarding warnings from critics that it could add to the growing opioid epidemic.
Produced by pharmaceutical company AcelRx under the brand name Dsuvia, the painkiller is a pill form of sufentanil, a powerful opioid that has been commonly used after surgery and in emergency care settings for over three decades. The new drug comes in a tablet form and is administered under the tongue via a single-dose applicator. It is 10 times more powerful than fentanyl and 1000 times stronger than morphine, and is intended to treat acute pain in healthcare settings.
Before getting the FDA’s approval, the new formulation of the drug was evaluated by FDA’s advisory board, Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC), who recommended it for approval in a 10 to 3 vote last month. Shortly thereafter, the panel’s chairman, Raeford Brown, MD, penned a statement to the FDA, urging the government organization to reject the drug. The letter states in part:
“I have developed a sensitivity to the harms that can be associated with the marketing of new opioid compounds and have been forced to consider the lack of ability of the agency to predict the behavior of opioid drugs and to enforce post-marketing regulation. It is my observation that 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. Briefly stated, for all of the opioids that have been marketed in the last 10 years, there has not been sufficient demonstration of safety, nor has there been post-marketing assessment of who is taking the drug, how often prescribing is inappropriate, and whether there was ever a reason to risk the health of the general population by having one more opioid on the market.”
Scott Gottlieb, MD, FDA commissioner, disagrees.
In a statement, Dr. Gottlieb notes that Dsuvia, which was developed in collaboration with the Department of Defense for potential use on the battlefield by trained personnel, was a priority for the Pentagon because it meets a specific and important “unmet medical need” for treating soldiers.
According to AcelRx, Dsuvia is meant as an alternative to the current intravenous (IV) opioid standard of care and as an effective, noninvasive option for patients for whom IV access is difficult.
“It’s an incremental advance in anesthesiology because it makes it easier to use opiates in some circumstances,” says Richard J. Miller, PhD, professor of pharmacology at Northwestern University Feinberg School of Medicine in Chicago. “It gives a certain amount of flexibility in the opiates they’re using in the clinic.”
The drug took nearly 15 years of research to develop, during which time the opioid crisis had yet to develop as rapidly as it is now. In 2017, about 72,000 Americans died from drug overdoses, according to preliminary estimates from the Centers for Disease Control and Prevention (CDC).
While the scientists creating the drug at the time worked with what they had, now it’s time to look at what’s happening and the lives being lost, says Anita Gupta, DO, PharmD,a board-certified anesthesiologist and clinical professor at Rowan University in Glassboro, New Jersey.
“At the same time, there are many people fighting for our country that are on the ground and soldiers that are being injured in the field that perhaps need pain control urgently and don’t have any other alternative,” she says. “What is the right answer? Right now, we don’t know. The bottom line is we need better solutions.”