AcelRx Reports Publication Of Zalviso Phase 3 Abdominal Trial Results

(RTTNews) - AcelRx Pharmaceuticals, Inc. (ACRX) reported that the results from the IAP310 study have been published in Regional Anesthesia and Pain Medicine (RAPM), a peer-reviewed journal with broad, multidisciplinary readership. IAP310 was a randomized, placebo-controlled, Phase 3 trial evaluating the safety and efficacy of Zalviso, also referred to as the sufentanil sublingual tablet system (SSTS), for the treatment of post-operative pain in patients following open abdominal surgery.

Zalviso is an investigational patient-controlled analgesia drug/device candidate currently under review by the Food and Drug Administration (FDA). 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 (p=0.001). 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 and using approximately half as much rescue morphine over the duration of the trial. 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.