Sufentanil sublingual tablets effectively control acute pain after outpatient abdominal surgery.
Results from a multicenter, randomized, placebo-controlled study suggest that 30-mg tablets are “efficacious and well tolerated across a variety of ambulatory surgery procedures for the management of moderate to severe acute postoperative pain,” said Pamela Palmer, MD, PhD, chief medical officer and co-founder of AcelRx Pharmaceuticals.
The sufentanil sublingual tablet (15 mcg) system is a noninvasive, patient-controlled analgesia product recently approved by the European Medicines Agency for treatment of postoperative pain in a hospital setting. The 30-mcg sufentanil tablet, which must be dispensed by a health care professional, is in Phase III development in collaboration with the Department of Defense for treatment of moderate to severe acute pain in settings including battlefield trauma, emergency medicine and ambulatory surgery. Dr. Palmer said sublingual sufentanil seems well suited for acute pain management because it is not invasive and is rapidly absorbed—within six minutes.
Effective for All Tested Surgeries
The study followed 160 adult patients for up to 48 hours after undergoing outpatient abdominal surgical procedures such as abdominoplasty, open tension-free inguinal hernioplasty and laparoscopic abdominal surgery. The patients were given a 30-mcg sufentanil tablet or placebo and asked to rate pain intensity on an 11-point scale, with 0 as no pain and 10 as worst possible pain. In addition, patients rated pain relief on a 5-point scale, with 0 as no relief and 4 as complete relief. The care team also monitored vital signs, oxygen saturation, adverse events and concomitant medicines.
Overall, patients given the sufentanil 30-mcg tablet showed statistically significant improvements in postoperative pain intensity compared with placebo. Broken down into subgroups, all surgery types showed significantly higher scores as well, including abdominoplasty, inguinal hernioplasty and laparoscopic abdominal surgery. Most adverse events were mild, with nausea, headache and vomiting being the most common. The team observed low levels of oxygen desaturation as well.
“Patient comfort and satisfaction postoperatively and time to discharge are critical end points, and sublingual sufentanil appears to address both of these,” Dr. Palmer said. “Sufentanil’s prompt absorption into the central nervous system and lack of active metabolites [predictable offset is in 2.5 to three hours] scientifically support such desirable outcomes.”
AcelRx is continuing the research as part of two ongoing Phase III trials, and hopes to submit a New Drug Application for sublingual sufentanil 30 mcg by the end of 2016.
Dr. Palmer presented the research (poster 44) as one of the four top poster presentations at the 2016 joint meeting of the Society for Ambulatory Anesthesia and the American Society of Anesthesiologists.