FDA Approves New Drug That Could Make the Opioid Epidemic Worse

As the opioid epidemic continues to surge through America, The Food and Drug Administration just approved a new form of an extremely powerful synthetic opiate. Several weeks ago, the chairman of the advisory committee warned that the approval of this drug could lead to “diversion, abuse, and death,” though it seems this warning has since been largely ignored by regulators at the FDA.

The drug in question is a sublingual tablet form of the drug called Dsuvia, which is delivered through a “prefilled, single-dose applicator.” Dsuvia is a new form of the extremely powerful opiate sufentanil, which is ten times stronger than fentanyl, and 500 – 1,000 times stronger than morphine. The use of Dsuvia will be limited to hospitals, surgery centers, and emergency rooms, and will not be available in any pharmacies or for home-use. Nevertheless, it is still another overpowered opiate that is being introduced during a time when there have been more than 40,000 opioid overdoses in a single year.

Photo by Jan Vanveen on Unsplash

Dsuvia was approved by the FDA’s advisory committee with a 10-3 vote in favor of the new drug. It was given a final approval on November 2, as FDA commissioned Dr. Scott Gottlieb issued a statement defending its approval, assuring precautions were being implemented to “help prevent misuse and abuse.”

Dr. Raeford Brown, chairman of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee, was quick to state the contrary. Dr. Brown released a letter co-signed by leaders of consumer advocacy group Public Citizen, which expressed doubts that the FDA has the capability to “regulate so that it is used only in closely controlled settings.” Brown states that the FDA has a history of not being able to contain the use of powerful synthetic opiates, pointing to the fact that fentanyl overdoses have led to thousands of deaths. Brown writes in the letter: “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.”

Sufentanil is so powerful, that any abusers of the drug could die from the first injected dose, and a pill form of this drug would only make it easier for opiate abusers to take. AcelRx, the company behind Dsuvia, issued a statement reaffirming their commitment to maximizing risk mitigation for the use of the drug. Vince Angotti, chief executive of AcelRx, says the company will be actively auditing wholesale distribution data, evaluating hospitals and healthcare professionals, and monitoring any abuse.