Background: Results from a phase-3, prospective, randomized, double-blind, placebo-controlled trial evaluating sufentanil sublingual tablet 30 mcg (SST) for the management of pain after ambulatory abdominal surgery are presented. Methods: Adults with American Society of Anesthesiologists status 1 to 3 scheduled to undergo abdominoplasty, open tension-free inguinal hernioplasty, or laparoscopic abdominal surgery under general or spinal anesthesia that did not include intrathecal opioids during the operation were eligible. Opioid-tolerant patients were excluded. The primary endpoint was the time-weighted summed pain intensity difference to baseline (SPID) over 12 hours. Secondary endpoints included SPID over 24 and 48 hours, total pain relief, and patient and healthcare professional (HCP) global assessments. Results: Overall, 161 patients were randomized to SST (N = 107) or placebo (N = 54); pain scores were recorded for up to 48 hours. SPID 12 was higher (greater pain intensity reduction from baseline) in the SST group compared with placebo (25.8 vs. 13.1; P < 0.001, with a difference of 12.7 [95% confidence interval 7.16, 18.23]). In the SST group, a greater proportion of patients and HCPs responded "good" or "excellent" on the global assessments compared with placebo (P < 0.001 for both). There was a numerically, but not statistically, higher incidence of nausea and headache in the SST group. Conclusions: In patients following abdominal surgery in an ambulatory care setting, SST was an effective opioid analgesic in postoperative pain management. In addition, SST was well tolerated with mild-to-moderate side effects, similar to those found in placebo-treated patients. &

SST 30 mcg was effective and well tolerated for the management of moderate-to-severe acute postoperative pain.

Background:A nanocrystal intravenous (IV) formulation of meloxicam is being studied with the aim of providing postoperative analgesia.Methods:This randomized, multicenter, double-blind, placebo-controlled trial evaluated meloxicam IV 30 mg or placebo (≤ 3 doses) in 219 subjects undergoing abdominoplasty. The primary endpoint was the summed pain intensity difference over 24 hours postdose (SPID24).Results:Meloxicam IV–treated subjects had a statistically significant reduction in the least squares mean of SPID24 compared with placebo-treated subjects (−4,262.1 versus −3,535.7; P = 0.0145). Meloxicam IV was associated with statistically significant differences over placebo on several other secondary endpoints, including other SPID intervals (ie, SPID12, SPID48, and SPID24–48), achievement of perceptible pain relief, the proportion of subjects with a ≥ 30% improvement in the first 24 hours, and Patient Global Assessment of pain at hour 48. Meloxicam IV was also associated with a reduction in the number of subjects receiving opioid rescue medication during hours 24–48 and the total number of doses of opioid rescue analgesia. Meloxicam IV was generally well tolerated, with the numbers and frequencies of adverse events similar to that of the placebo group. There was no evidence of an increased risk of adverse events commonly associated with nonsteroidal anti-inflammatory drugs including bleeding, thrombotic, cardiovascular, renal, hepatic, cardiovascular, injection site, and wound healing events.Conclusion:Meloxicam IV provided sustained pain relief and generally was well tolerated in subjects with moderate-to-severe pain following abdominoplasty.

The sufentanil sublingual tablet (SST) offers an advantage over intravenous opioids with regard to its noninvasive route of administration.• For the current analysis, safety data were pooled from the three Phase III studies of the SST 30 mcg in patients following surgery or in an emergency department. An additional subset of postoperative patients who self-administered SST 15 mcg in three Phase II and three Phase III studies were included in the pooled analysis if two SST 15-mcg doses were received within 20-25 min (30-mcg dose-equivalent).• Study drug exposure data, adverse events (AEs) and oxygen saturation data, as well as time to SST dissolution and morphine equivalence were analyzed. • A total of 804 patients were included in the safety analysis.• AEs were experienced by 60.5% (SST) and 61.4% (placebo) and treatment-related AEs were experienced by 43.8% (SST) and 33.5% (placebo) (10.3% difference; 95% CI: 2.0-18.6) of patients. Differences were significant for treatment-related AEs but not for AEs overall. • Across all studies, nausea, which occurred in 34.1% of patients receiving SST, was the only moderate AE that occurred in >5% of patients. • No dose-dependent increase in oxygen desaturation events was observed with SST.• Findings from the pooled analysis support that SST is well tolerated, with most AEs considered mild or moderate in severity, for the treatment of moderate-to-severe acute pain in medically supervised settings.Aim: To evaluate the pooled safety of sufentanil sublingual tablets (SSTs) administered at 30-mcg dose equivalents over ≤72 h for moderate-to-severe acute pain management in medically supervised settings.Patients & methods: Safety data from SST 30 mcg Phase III studies were pooled with an additional patient subset from studies in which two SST 15 mcg were self-administered within 20-25 min (30-mcg doseequivalent). Results: Analyses included 804 patients. Median (range) SST 30-mcg dosing over 24 h was 7.0 (1-15) tablets. Adverse events (AEs) were experienced by 60.5% (SST) and 61.4% (placebo) and treatmentrelated AEs by 43.8% (SST) and 33.5% (placebo; 10.3% difference; 95% CI: 2.0-18.6) of patients. No dosedependent increase in oxygen desaturation was observed with SST. Conclusion: SST was well-tolerated, with most AEs considered mild or moderate in severity.