Patient and Healthcare Professional Satisfaction Ratings and Safety Profile of Sufentanil Sublingual Tablets for Treatment of Acute Pain: A Pooled Demographic Analysis
Authors Leiman D, Jové M, Spahn GR, Palmer P
Received 10 November 2020
Accepted for publication 2 March 2021
Published 25 March 2021 Volume 2021:14 Pages 805—813
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 3
Editor who approved publication: Dr Erica Wegrzyn
David Leiman,1,2 Maurice Jové,3 Gail Rosen Spahn,4 Pamela Palmer4
1HD Research, Houston, TX, USA; 2University of Texas at Houston, Department of Surgery, Houston, TX, USA; 3Atlanta Bone and Joint Specialists, Atlanta, GA, USA; 4Medical Affairs, AcelRx Pharmaceuticals, Inc, Redwood City, CA, USA
Correspondence: David Leiman Email [email protected]
Objective: This analysis reports the healthcare professional global assessment (HPGA) and patient global assessment (PGA) scores and the adverse event (AE) profile by age, body mass index (BMI), sex, and race from the three Phase III registration studies for sufentanil sublingual tablet (SST) 30 mcg.
Methods: Global assessments and treatment-related AEs were analyzed from patients treated with SST 30 mcg for moderate-to-severe acute pain following surgery or in the emergency department (ED). Pooled data were analyzed across patient demographic subgroups.
Results: A total of 283 patients were included in the HPGA/PGA analyses. The majority underwent abdominal surgery, with the remaining patients undergoing orthopedic or “other” types of surgery. Overall, SST 30 mcg was highly rated by both healthcare professionals and patients across the demographic subgroups. A total of 323 patients were included in the safety evaluation. The majority of patients did not experience any SST-related AEs; however, those that did experienced common opioid-related side effects such as nausea, headache, dizziness, and vomiting. No patients experienced unexpected AEs or required the use of naloxone.
Conclusion: SST 30 mcg was highly rated and well tolerated across demographic subgroups with the majority of patients not experiencing any adverse event related to SST 30 mcg. These findings support the use of sublingual sufentanil in all adult patients, regardless of age, BMI, sex, or race for the treatment of moderate-to-severe acute pain.
Keywords: acute pain, demography, global assessment, sublingual administration, sufentanil, surgery
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