Objective. To evaluate sufentanil sublingual tablet 30 mcg (SST 30 mcg) for postoperative pain in an older patient population with comorbidities. Design. Multicenter, open-label, single-arm study. Setting. Nine hospitals across the United States. Subjects. Adults aged ≥40 years who had undergone a surgical procedure. Methods. Patients with a postoperative pain intensity score ≥4 on an 11-point numeric rating scale (NRS) were allowed to enter the study and receive SST 30 mcg as requested for pain (minimum 60-minute redosing interval) over the 12-hour study period. Efficacy was assessed by patient reports of pain intensity on the NRS and a five-point pain relief scale. Safety was monitored throughout the study; plasma sufentanil concentrations were also measured. The primary efficacy endpoint was the time-weighted summed pain intensity difference (SPID) to baseline over 12 hours (SPID12). Results. Of the 140 patients enrolled, 69% were American Society of Anesthesiologists Physical Class II or III, 44% had a body mass index (BMI)≥30 mg/kg2, and 29% had hepatic and/or renal impairment. Average age was 54.7 years (SD=9.9 years), and average baseline pain intensity was 6.2 (SD=1.9). The most common surgeries were abdominal (59%) and orthopedic (20%). The mean SPID12 was 36.0 (standard error of the mean = 2.2); mean scores were similar, regardless of age, sex, race, and BMI. From baseline, mean pain intensity decreased significantly starting 30 minutes postdose, and mean pain relief increased significantly starting 15 minutes postdose, remaining relatively stable through 12hours (P < 0.001 at each time point). Four (3%) patients discontinued due to inadequate analgesia, and 45 (32%) patients had one or more adverse events that were considered possibly or probably related to the study drug. Mean plasma sufentanil concentrations were generally similar regardless of age, sex, BMI, or organ impairment status. Conclusions. SST 30 mcg was effective and well tolerated for the management of moderate-to-severe acute postoperative pain.
Bibliographical noteFunding Information:
This study was funded by AcelRx Pharmaceuticals and by the Clinical and Rehabilitative Medicine Research Program (CRMRP) of the US Army Medical Research and Materiel Command (USAMRMC) under contract No. W81XWH-15-C-0046. The CRMRP was established in 2008 to foster research and technology advances for the regeneration, restoration, and rehabilitation of traumatic injuries. In accordance with USAMRMC guidelines, in the conduct of clinical research, AcelRx has adhered to the policies regarding the protection of human subjects as prescribed by Code of Federal Regulations (CFR) Title 45, Volume 1, Part 46; Title 32, Chapter 1, Part 219; and Title 21, Chapter 1, Part 50 (Protection of Human Subjects). JH, DL, HM, and MJ were investigators of this study; their institutions received funding for their participation in the trial. JH is also a consultant, speaker, and has received research funding from Pacira Pharmaceuticals. He also owns stock options in Insitu Biologics. HM is also a consultant to AcelRx. KPD is an employee and has stock ownership of AcelRx Pharmaceuticals. PPP is an employee and has stock ownership of AcelRx Pharmaceuticals. The authors would like to thank Melissa Cohen (research assistant to JLH) at the University of Minnesota, Minneapolis, Minnesota, for aiding in patient recruitment and data collection. The authors would also like to thank Pam Lindley (research nurse to HM) and the research team at Research Concepts GP, LLC, Bellaire, Texas, for their assistance in executing the study. Editorial assistance was provided by Penny Baron and Robert Steger (BlueMomentum, a division of Ashfield Healthcare Communications, a UDG Healthcare plc company), Burlingame, California, and funded by AcelRx Pharmaceuticals.
- Open-label trial
- Opioid analgesic
- Pain assessment
- Postoperative pain