Why the concern? First, sublingual and transmucosal fentanyl already exist (eg, Actiq, Abstral, and Fentora). None of these agents is in widespread use in emergency medicine or in EMS. The “unmet need” cited by AxelRx doesn’t seem to exist. However, among the opioids in use in both emergency departments and the prehospital environment, there are already problems with diversion of drugs by addicted personnel.² Why bring a fresh marketing campaign supporting a new formulation of a highly potent opioid that is easier to use and therefore abuse than existing drugs? Why allow a drug company to create a sense of need around a dangerous drug that isn’t actually meeting patients’ needs? What is the real benefit to emergency department or EMS operations to balance out the incredible risk this drug presents? For these reasons, the ACEP Council approved the resolution, and the Board has provided written testimony to the FDA opposing the approval of sublingual sufentanil.

Quoting ACEP’s letter to the FDA, “There are no data to indicate that pharmacokinetic failure of currently available narcotics via existing routes and formulations is a problem in EMS or emergency medicine.”³ So I ask you, can we stop the madness?

References

1. DSUVIA. AcelRx Pharmaceuticals website. Accessed Oct. 27, 2017.
2. Avsec R. Substance abuse programs: what EMTs and paramedics need to know. EMS1 website. Accessed Oct. 27, 2017.
3. ACEP letter to the FDA, Feb. 2, 2017. ACEP website. Accessed Oct. 27, 2017.