Pooled Phase III safety analysis of sufentanil sublingual tablets for short-term treatment of moderate-to-severe acute pain.

Abstract

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 dose-equivalent). 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 treatment-related AEs by 43.8% (SST) and 33.5% (placebo; 10.3% difference; 95% CI: 2.0-18.6) of patients. No dose-dependent increase in oxygen desaturation was observed with SST. Conclusion: SST was well-tolerated, with most AEs considered mild or moderate in severity.

• Authors: James R Miner, Timothy I Melson, David Leiman, Harold S Minkowitz, Yu-Kun Chiang, Karen P DiDonato, Pamela P Palmer
• Journal: Pain management (Pain Manag) Vol. 9 Issue 3 Pg. 259-271 (May 2019) ISSN: 1758-1877 [Electronic] England
• PMID: 30614379 (Publication Type: Clinical Trial, Phase III, Journal Article)

Chemical References

• Analgesics, Opioid
• Tablets
• Sufentanil

Topics

• Acute Pain (drug therapy)
• Administration, Sublingual
• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Analgesics, Opioid (administration & dosage, adverse effects, therapeutic use)
• Female
• Humans
• Male
• Middle Aged
• Sufentanil (administration & dosage, adverse effects, therapeutic use)
• Tablets
• Time
• Young Adult