The Food and Drug Administration has approved a controversial new form of the powerful synthetic opiate sufentanil for managing acute pain in adults, just weeks after the chairman of the advisory committee warned that doing so would lead to “diversion, abuse and death.” Sufentanil has been used intravenously since the 1980s, but pharmaceutical company AcelRx has developed a sublingual tablet form of the drug called Dsuvia, which is delivered through a “pre-filled, single-dose applicator.” Ten times stronger than fentanyl and 500 to 1,000 times stronger than morphine, Dsuvia will be restricted to limited use only in health care settings, such as hospitals, surgery centers and emergency rooms, and will not be available in pharmacies or for home-use; nevertheless, critics fear the drug will contribute to an already devastating opioid crisis, including more than 40,000 overdose deaths last year.
On October 12th, the FDA’s advisory committee evaluated Dsuvia and voted 10-3 in favor of approving the drug; after the agency issued their final approval on Friday, November 2nd, Dr. Scott Gottlieb, the FDA commissioner, released a statement defending the decision and emphasizing the measures being taken to limit its use and “help prevent misuse and abuse.”
According to a statement from Vince Angotti, the chief executive of AcelRx, the company’s risk evaluation and mitigation strategy includes auditing wholesale distribution data; evaluating hospitals and other health care providers to ensure that the drug is being administered properly; and monitoring for any diversion or abuse.
Dr. Raeford Brown, the chairman of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC), was not able to attend the meeting and vote in October due to a prior commitment, but he urged the agency’s top officials to reject Dsuvia in a strongly worded letter co-signed by leaders of the consumer advocacy group Public Citizen. Brown expressed strong doubts that the agency has the capability to “regulate [Dsuvia] so that it is used only in closely controlled settings” and “only as described in the label.”
According to Brown, historically, the FDA has not demonstrated an ability to enforce such controls with any other opioid, and “there is currently no educational nor regulatory scheme” in place that guarantees the agency’s approach to regulating Dsuvia will be any different.
“It is my observation that once the F.D.A. 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,” Brown wrote in the letter.
Brown, an anesthesiology professor at the University of Kentucky, said the IV form of sufentanil is so potent that “abusers … often die when they inject the first dose,” and warned that regardless of its form, the small dosing volume made it easier to divert and abuse. Brown also questioned why the FDA’s full Drug Safety and Risk Management Advisory Committee (DSRMAC) did not participate in the October meeting, suggesting it “increased the odds of a vote favoring FDA approval.”
The FDA did not immediately respond to Rolling Stone’s request for comment, but a spokesperson told the New York Times that “there were drug safety and risk experts on the committee whose expert input was taken very seriously throughout this process.”
Dsuvia is expected to hit the market early next year.