A Review of Sufentanil and the Sufentanil Sublingual Tablet System for Acute Moderate to Severe Pain

SUMMARY 

The sufentanil sublingual tablet system (SSTS) is a novel patient-controlled analgesia (PCA) system that is pending approval from the US FDA for the management of moderate to severe acute pain in hospitalized patients. SSTS offers a noninvasive alternative to intravenous (iv.) PCA and optimized on-demand analgesia with the rapid onset and titratibility of sublingual sufentanil. Phase III clinical trials have demonstrated that SSTS has greater efficacy for the treatment of pain during the 72-h postoperative period after open abdominal and major orthopedic (total knee or total hip arthroplasty) surgery compared with iv. PCA with morphine sulfate (MS) or a placebo system. Safety assessments indicate that adverse events are typical for postoperative patients taking opioid analgesics. While the frequency of adverse events is comparable between patients using SSTS and iv. PCA MS, the incidence of oxygen desaturation is lower in those using SSTS.

KEYWORDS :

• acute postoperative pain
• opioid
• pain management
• patient-controlled analgesia
• sublingual administration
• sufentanil

Financial & competing interests disclosure

H Minkowitz received research funding from AcelRx Pharmaceuticals and The Medicines Company to conduct clinical studies for the evaluation of sublingual sufentanil and the fentanyl iontophoretic transdermal system, respectively, for the management of acute postoperative pain. He is also a consultant for The Medicines Company. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Writing and editorial assistance were provided by BlueMomentum, an Ashfield Company, part of UDG Healthcare plc, and funded by AcelRx Pharmaceuticals.

Additional information

Funding

H Minkowitz received research funding from AcelRx Pharmaceuticals and The Medicines Company to conduct clinical studies for the evaluation of sublingual sufentanil and the fentanyl iontophoretic transdermal system, respectively, for the management of acute postoperative pain. He is also a consultant for The Medicines Company. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Writing and editorial assistance were provided by BlueMomentum, an Ashfield Company, part of UDG Healthcare plc, and funded by AcelRx Pharmaceuticals.