Jacob Hutchins, MD1, David Leiman, MD2, Karen DiDonato, MSN, RN3, Pamela Palmer, MD, PhD3. 1University of Minnesota, 2Victoria Medical Center, 3AcelRx Pharmaceuticals
OBJECTIVE: Following completion of a comprehensive clinical program, the Sufentanil Sublingual Tablet 30 mcg (“SST 30 mcg”; DSUVIA™) was recently approved by the U.S. FDA for management of acute pain in adults severe enough to require an opioid analgesic and for which alternative treatments are inadequate. SST 30 mcg can only be administered in a medically supervised setting such as hospitals, the Emergency Department and surgery centers and appears well-suited for short duration acute pain management because it acts rapidly, does not require an invasive route of delivery and possesses a predictable off-set. Three phase 3 trials were conducted; one randomized and placebo-controlled in post-operative abdominal patients and two open-label and single-arm intended to evaluate SST 30 mcg in the Emergency Department (ED) and in older, post-operative patients. The primary objective of this analysis was to examine the key efficacy and safety results by surgery type for patients who were treated with SST 30 mcg following various abdominal surgery procedures.
METHODS: Two of the three studies enrolled abdominal surgery patients: one randomized and placebo-controlled for up to 48 hours in adult patients undergoing laparoscopic abdominal surgery, hernia repair or abdominoplasty and the other open label evaluating SST 30 mcg in older adults (≥ 40 years) following laparoscopic abdominal or orthopedic surgery. All patients provided IRB-approved informed consent. Efficacy was assessed by patient reports of pain intensity on an 11-point numerical rating scale (0 = no pain, and 10 = worst possible pain), with the primary outcome measure as the Summed Pain Intensity Difference to baseline over the 12-hour study period (SPID12). Safety was assessed via vital signs, oxygen saturation monitoring, adverse events (AEs) and concomitant medications. An a priori subgroup analysis by surgery type was additionally performed to assess for potential differences in efficacy or safety.
RESULTS: A total of 161 (107 SST 30 mcg, 54 Placebo) and 140 patients, respectively were enrolled in the placebo-controlled and open-label trial. Of those, 244 (81%) underwent abdominal surgery (laparoscopic abdominal [n=106], abdominoplasty [n=80], open hernia  and other [n=5].) Statistically significant LS mean SPID12 differences were observed in favor of SST 30 mcg over placebo for abdominoplasty (30.8 vs 17.6; p=0.001) and laparoscopic abdominal patients (21.4 vs 8.2; p=0.019) in the RCT. Reductions in pain intensity were numerically greater for hernia patients assigned to SST 30 mcg compared to placebo (18.6 vs 7.7), but did not reach significance, likely due a small sample size. In the open label study, mean pain intensity for abdominal surgery patients significantly decreased from baseline starting at 30 minutes post-dose and remained relatively stable for the duration of the 12-hour study period (P<0.001 at each time point). The most frequently reported AEs across all surgery cohorts was nausea (29.6%) and headache (9.6%) with no significant differences between active and placebo.
CONCLUSION: SST 30 mcg has shown benefit across a variety of postoperative abdominal patients as a non-invasive analgesic modality for short-term management of acute moderate-to-severe pain.
Presented at the SAGES 2017 Annual Meeting in Houston, TX.
Abstract ID: 98914
Program Number: ETP748
Presentation Session: Emerging Technology Poster Session (Non CME)
Presentation Type: Poster