Phase III data on Zalviso for Post-Operative Pain published-AcelRX Pharma

AcelRx Pharmaceuticals has announced that results from the IAP310 Phase III trial evaluating the safety and efficacy of Zalviso (sufentanil sublingual tablet system (SSTS)) for the treatment of Post-operative Pain in patients following open abdominal surgery. Data have been published in Regional Anesthesia and Pain Medicine. The study met its primary endpoint, demonstrating that Zalviso was significantly better at managing pain over 48 hours as measured by Summed Pain Intensity Difference to Baseline (SPID-48), than placebo. Zalviso-treated patients had pain scores that separated from placebo-treated patients within 1 hour after study initiation. The IAP310 study results had been previously reported, however this publication represents the first time the results have been included in a peer-reviewed journal.

Treatment-related adverse events were similar between the two groups, with fewer Zalviso patients dropping out of the study due to inadequate analgesia compared to placebo (17.4% vs 31.8%) and using approximately half as much rescue morphine over the duration of the trial (1.8 doses vs. 3.8 doses). As a secondary endpoint, a validated ease-of-care questionnaire was administered to patients and healthcare providers. Both groups gave Zalviso a total overall rating above 4.0 on a scale of 0-5. The authors conclude that Zalviso may integrate well with a multimodal approach to acute pain management in the hospital setting.