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

Abstract

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.

CYP3A4 gene polymorphism is correlated with individual consumption of sufentanil

“…However, IV‐PCA is still associated with certain issues, such as IV‐PCA‐related technical errors, IV‐PCA by proxy and catheter‐related risks . IV‐PCA by proxy has been reported to be related to respiratory‐related events and death .…”

Non-invasive patient-controlled analgesia in the management of acute postoperative pain in the hospital setting

“…The sufentanil sublingual tablet system (SSTS) is a pre-programmed, non-invasive, handheld device which dispenses a single sufentanil bioadhesive nanotablet (3 mm in diameter, 0.75 mm thickness; 15 lg), with a minimum 20 minute interdose lockout period 63 . The dispenser can be used by the same patient over the course of 3 days of treatment; prefilled cartridges contain 40 tablets (providing about a 2 day supply) and cartridges are discarded after patient use.…”

“…The pre-programmed device uses a radiofrequency identification thumb tag, which allows self-administration only by the assigned patient (healthcare providers or patient relatives cannot administer the drug); this aspect of the SSTS decreases the most common issues associated with conventional PCA systems. Moreover, the SSTS is able to display a digital tablet count which allows the course of medication demand to be assessed 63 .…”

Between evidence and commerce – the case of sufentanil sublingual tablet systems

“…Further, looking through the retrieved titles of the Pubmed search, we were surprised to find seven review articles published between November 2015 and February 2017 regarding the use of sublingual sufentanil nanotablets for the treatment of pain 14, 15, 16, 17, 18, 19, 20. All seven reviews included the same original articles, sometimes citing each other 14, 15, 18, 19 or providing the same figures 14, 17, 19 or similar tables 14, 17, 19.…”

“…All seven reviews included the same original articles, sometimes citing each other 14, 15, 18, 19 or providing the same figures 14, 17, 19 or similar tables 14, 17, 19. The publication of seven reviews in 16 months, all independently reviewing the same evidence, led us to consider how many original publications about sublingual sufentanil existed altogether.…”