Purpose: To aid nurses in dosing sufentanil sublingual tablet (SST) 30 mcg administered via a single-dose applicator, dosing requirements and efficacy of SST 30 mcg were analyzed across age, sex, race, and body mass index subgroups. Design: Patient characteristics were pooled from three postoperative studies (two placebo-controlled and one open-label) and one open-label emergency department study. Drug dosing and efficacy data were pooled from the postoperative studies. Methods: Efficacy was assessed through summed pain intensity difference to baseline during 12 hours across subgroups. Findings: Mean (standard deviation) drug doses administered from 0 to 12 hours was 3.9 (2.0) for SST 30 mcg and was less frequent for older (≥65 years) versus younger patients. The summed pain intensity difference to baseline during 12 hours was superior with SST 30 mcg versus placebo across all subgroups. Conclusions: SST 30 mcg is a sublingual opioid analgesic with efficacy across demographic subgroups.
Bibliographical noteFunding Information:
Funding: These studies were funded by AcelRx Pharmaceuticals. Three of the studies were also funded by the Clinical and Rehabilitative Medicine Research Program of the US Army Medical Research and Materiel Command under contract nos. W81XWH-15-C-0046 (SAP302 and SAP303) and W81XWH-11-1-0361 (SAP202).Editorial assistance, including literature review and drafting and copy editing the manuscript, was provided by Rob Steger and Penny Baron (Ashfield Healthcare Communications, a UDG Healthcare plc company), New York, USA, and funded by AcelRx Pharmaceuticals. Statistical analysis was provided by Yu-Kun Chiang, PhD (statistical consultant for AcelRx).
© 2019 The Authors
Copyright 2020 Elsevier B.V., All rights reserved.
- acute pain