Introduction
Opioids often are considered standard-of-care treatment for acute pain associated with field trauma; however, limitations of these therapies have been well documented. Morphine is associated with erratic onset of analgesia when delivered intramuscularly (IM) and delayed side effects resulting from active metabolites, and fentanyl's rapid distribution demands frequent redosing. There remains a clinical need for rapid-acting, potent analgesics that do not require an invasive route of delivery. In collaboration with the Department of Defense, a sufentanil sublingual 30 mcg tablet (SST) is in development for treatment of acute pain in battlefield and emergency trauma settings.
Objective
To evaluate SST’s safety and efficacy in managing moderate-to-severe pain in the emergency department (ED).
Methods
This is a multicenter, open-label, phase 3 study in up to 120 adult patients presenting to the ED with acute traumatic pain. SST was administered as needed but not more frequently than hourly. Efficacy was assessed by patient reports of pain intensity on an 11-point numerical rating scale (0 = no pain and 10 = worst possible pain). The primary efficacy variable was the summed pain intensity difference from baseline over the first hour (SPID1). Safety was assessed via vital signs and adverse event reporting (AEs).
Results
Forty of the 120 patients have been enrolled to date and an interim analysis performed. Statistically significant and clinically meaningful reductions in pain intensity have been observed following a single dose of SST. A low number of adverse events has been reported, with nausea and somnolence the most frequent (5% each). If selected for presentation, complete top-line results from the entire cohort will be presented.
Conclusions
Sufentanil 30 mcg tablets are in development for treatment of moderate-to-severe acute pain in an EM population. Early efficacy and tolerability results suggest that SST may offer a viable alternative to IM or IV dosing.
Funding
The late-stage development of this drug is being sponsored in part by the US Department of Defense