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Sublingual Sufentanil Reduces Postoperative Pain in Phase III Study

PCA drug/device candidate is currently under FDA review

Positive results have been reported from a phase III trial evaluating the safety and efficacy of Zalviso (AcelRx Pharmaceuticals) –– also known as the sufentanil sublingual tablet system (SSTS) –– for the treatment of moderate-to-severe postoperative pain after major joint-replacement surgery. The findings were published in the June 2015 issue of Anesthesiology.

Zalviso is an investigational patient-controlled analgesia (PCA) drug/device candidate currently under review by the FDA.

The randomized, double-blind, placebo-controlled study met its primary endpoint, demonstrating that SSTS (15 mcg) was significantly better at managing pain over 48 hours, as measured by Summed Pain Intensity Difference to Baseline (SPID-48), than placebo (P < 0.001). The SPID-48 score was 76 for SSTS compared with –11 for placebo, for a difference of 88. SSTS-treated patients had pain relief scores superior to those of placebo-treated patients within 45 minutes after study initiation.

Reports of treatment-related adverse events were similar between the two groups, with the exception of nausea and itching, which were more common in the SSTS group. Fewer SSTS-treated patients withdrew from the study because of inadequate analgesia compared with placebo-treated patients (14% vs. 48%, respectively; P < 0.001). In addition, the SSTS group used approximately half as much rescue morphine over the duration of the trial compared with the placebo group (2.3 doses vs. 4.0 doses, respectively).

As a secondary endpoint, a validated ease-of-care questionnaire was administered to patients and health care providers. Both groups gave SSTS a total overall rating above 4 on a scale of 0 to 5.

The authors concluded that SSTS may integrate well with a multimodal approach to acute pain management in the hospital setting.

Sources: AcelRx Pharmaceuticals; July 2, 2015; and Anesthesiology; June 2015.


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