Patient and Healthcare Professional Satisfaction Ratings and Safety Profile of Sufentanil Sublingual Tablets for Treatment of Acute Pain: A Pooled Demographic Analysis.

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.