Sufentanil 30 µg Sublingual Tablet: A Review in Acute Pain

The sufentanil 30 μg sublingual tablet (hereafter referred to as the sufentanil ST) is approved in the EU for acute moderate to severe pain in adults (Dzuveo™) and in the USA for acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate (Dsuvia™). It is a single-strength tablet housed in a single-dose applicator (which may minimize the likelihood of dosing errors) and is strictly for use in medically supervised/monitored settings. It is administered by a healthcare professional and has a minimum re-dose interval of 1 h and no drug delivery setup requirements. In placebo-controlled or noncomparative phase 2 or 3 trials, the sufentanil ST provided effective analgesia for adults with moderate to severe acute pain due to surgery or trauma/injury, reducing the intensity of pain within 15-30 min after the first dose and maintaining analgesic benefit over the 2-24 h study periods. Such short-term use of the sufentanil ST was also generally well tolerated. Studies directly comparing the sufentanil ST with other opioids in terms of efficacy, tolerability, usability and cost effectiveness would be beneficial, as would analyses of its abuse potential, given sufentanil is considerably more potent than fentanyl or morphine. In the meantime, current data indicate that the sufentanil ST is a noninvasive, fast-acting, opioid formulation for managing moderate to severe acute pain in medically supervised/monitored settings that may be of particular use when oral or intravenous opioid analgesia is not possible/feasible.