AcelRx' Zalviso meets primary endpoint in Phase III trial of post-surgery pain

Phase III results of AcelRx Pharmaceuticals’ (Nasdaq: ACRX) trial of Zalviso (sufentanil) have shown that the drug met its primary endpoint in the treatment of moderate-to-severe post-operative pain in patients following major joint replacement surgery.

Zalviso is an investigational patient-controlled analgesia drug/device candidate under review by the US Food and Drug Administration. Zalviso met its primary endpoint, showing that it was significantly better at managing pain over 48 hours as measured by Summed Pain Intensity Difference to Baseline (SPID-48) than placebo. Patients treated with Zalviso had pain relief scores superior to those treated with Zalviso within 45 minutes of study initiation.

Treatment-related adverse events were similar between the two groups, but nausea and itching were higher in the Zalviso group. Fewer Zalviso patients dropped out of the study due to inadequate analgesia compared to placebo (14% compared to 48%).