Zalviso sublingual tablets are self-administered by the patient in response to pain, using the hand-held administration device. They are only for use in hospital and must be prescribed by a specialist in opioid therapy. The device provides a minimum lock-out period of 20 minutes between doses.
Zalviso is intended to overcome the limitations of intravenous patient-controlled analgesia, such as medication delivery errors and complications associated with intravenous delivery.
The maximum recommended duration of treatment is 72 hours.
Post-operative pain relief
The efficacy of sublingual sufentanil was shown in three phase III trials in acute pain following major or surgery: two double-blind placebo-controlled trials (sufentanil, n=430; placebo, n=161) and one (sufentanil, n=177; morphine, n=180).
In the three trials, sublingual sufentanil was superior to placebo for the primary endpoint, time-weighted sum of pain intensity difference (SPID) from baseline over 48 hours (p≤0.001), and the secondary endpoints, time-weighted SPID (p≤0.004), total pain relief (p≤0.004), and patients global assessment (p≤0.007) over 24, 48 and 72 hours.
In the active-controlled study, a significantly higher proportion of patients rated pain control as 'good' or 'excellent' with sufentanil than with morphine (78.5% vs 65.5%, p=0.007).
Patients in all three studies reported clinically meaningful pain relief within the first hour of treatment with sufentanil, and sufentanil was also considered to be easier to use by healthcare professionals.
Nausea and vomiting were the most frequently reported adverse reactions to sufentanil. As an opioid, sufentanil can cause dose-related respiratory depression. Patients with respiratory impairment or reduced respiratory reserve are at higher risk and patients with significant existing respiratory depression should not be given sufentanil.
The effects of sufentanil can be blocked immediately by a specific opioid antagonist such as naloxone.