INTRODUCTION: The sufentanil sublingual tablet system is a non-invasive, patient-controlled analgesia product that received EU marketing authorization in September 2015.   A second sufentanil product, a 30 mcg tablet (ST30) dispensed sublingually by a healthcare professional, is in Phase 3 development for treatment of moderate-to-severe pain in settings such as ambulatory surgery.  Sublingual sufentanil appears well-suited for short duration acute pain management because it acts rapidly, does not require an invasive route of delivery and possess a predictable off-set. The primary objective of this study was to compare the efficacy and safety of ST30 to placebo (PT) for the management of moderate-to-severe acute pain following outpatient surgery.
METHODS: The study was randomized and placebo-controlled for up to 48 hours in adult patients undergoing abdominoplasty, open tension-free inguinal hernioplasty or laparoscopic abdominal surgery. Following Ethics Committee approval and patient informed consent, approximately 160 patients were randomly assigned to treatment with ST30 or PT. Efficacy was assessed by patient reports of pain intensity on an 11-point numerical rating scale (0 = no pain, and 10 = worst possible pain) and the primary efficacy variable was the time-weighted summed pain intensity difference to baseline over 12 hours (SPID12). Key secondary endpoints included total pain relief (TOTPAR) and patient and healthcare professional global assessments (PGA and HPGA). Safety was assessed via vital signs, adverse events (AEs) and the use of concomitant medications.
RESULTS: A total of 161 (107 ST and 54 PT) patients were randomized and received study drug.  Average patient age was 41 years; 68% were female. Statistically significant SPID12 differences were observed in favor of ST over PT (25.8 vs. 13.1; p<0.001), demonstrating superiority for management of acute post-operative pain. Several secondary endpoints also met statistical significance in favor of ST including TOTPAR, PGA and HPGA (p≤0.001 for all). Nausea, headache and vomiting were the most common treatment-emergent AEs across both treatment arms.
DISCUSSION/CONCLUSION: The sufentanil sublingual 30 mcg tablet has demonstrated benefit over placebo as a non-invasive analgesic modality in medically supervised settings requiring short-term treatment of acute moderate-to-severe pain. Global assessment results by patients and healthcare professionals suggest the therapy is effective, well-tolerated and easy to administer.

Safety and efficacy of sufentanil sublingual 30 mcg tablets for the treatment of acute pain following outpatient surgery