Much has been written about the opioid crisis in America. Alternative medication regimens have been proposed. The lack of treatment centers has been lamented, and everyone from politicians to the lay public, insurance companies, and physicians have practically tripped over one another to point fingers of blame. What has not been identified as a problem is a lack of options for opioid analgesia, in terms of specific medications or routes of administration. This “lack of a problem” has not stopped drug companies from coming up with solutions.
One such company, AcelRX, began a push to market Dsuvia, a 30 mcg sufentanil sublingual tablet (then called ARX-04), during the end of its phase III trial period in September 2016. In communications from AcelRx sent to several emergency physicians ahead of the ACEP16 conference, as well as several paramedics in advance of the 2016 EMS World Expo, the manufacturer extended an invite to attend a paid dinner “to discuss the science behind sublingual sufentanil, present more comprehensive data from the recently completed phase three trials, as well as gain an understanding of the patient populations that might receive the most benefit from ARX-04 therapy.” (Disclaimer: This author was invited but did not attend.)
AcelRx developed ARX-04 in part through a grant from the US Army Medical Research and Materiel Command administered through the Defense Advanced Research Projects Agency (DARPA). Its stated purpose was to find an alternative to parenteral opioids for the treatment of moderate to severe pain during battle conditions.
It became obvious through multiple emails and phone calls from AcelRx to emergency physicians and EMTs that the company was intent not only on providing this “new” drug to soldiers in battle but also marketing it for use in emergency departments and prehospital emergency medicine. Its website suggests that this would be a market with potential sales of more than $1 billion.1 Company officials made several statements to emergency physicians that EMS agencies were actively requesting this drug to fill a “huge unmet need,” yet no EMS medical director sitting on the ACEP EMS Committee or attending the EMS World Expo had identified a need for sublingual analgesia on their units, let alone made any request of AcelRx. For that reason, two ACEP members, one from the Trauma & Injury Prevention Section (Megan L. Ranney, MD, MPH, FACEP) and another from the EMS Section (myself), brought forward a resolution to the ACEP Council asking that the College actively oppose the FDA approval of ARX-04 for use in emergency medicine or EMS.
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?
- DSUVIA. AcelRx Pharmaceuticals website. Accessed Oct. 27, 2017.
- Avsec R. Substance abuse programs: what EMTs and paramedics need to know. EMS1 website. Accessed Oct. 27, 2017.
- ACEP letter to the FDA, Feb. 2, 2017. ACEP website. Accessed Oct. 27, 2017.