Results from Phase 3 study evaluating safety and efficacy of Zalviso published in Anesthesiology

AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced that results from the IAP311 study have been published in Anesthesiology. IAP311 was a randomized, double-blind placebo-controlled, Phase 3 trial evaluating the safety and efficacy of Zalviso, also referred to in the publication as the sufentanil sublingual tablet system (SSTS), for the treatment of moderate-to-severe post-operative pain in patients following major joint replacement surgery. Zalviso is an investigational patient-controlled analgesia (PCA) drug/device candidate currently under review by the United States 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 relief scores superior to placebo-treated patients within 45 minutes of study initiation. The IAP311 study results had been previously reported; however, this publication represents the first time the results have been included in a peer-reviewed journal.

"While opioids remain a critical component of multimodal post-operative analgesia, what's new and novel about Zalviso is that it is non-invasive and can be safely controlled by the patient," said lead investigator Maurice Jove, MD, Medical Director of the Joint Solutions Center at Dekalb Medical Center in Decatur, GA. "For patients, this means that Zalviso, if approved, could potentially offer an effective alternative to standard intravenous PCA."

Reports of treatment-related adverse events were similar between the two groups, with the exception of nausea and itching, which were higher in the Zalviso group. It was noted that fewer Zalviso patients dropped out of the study due to inadequate analgesia compared to placebo (14% vs 48%; p<0.001) and used approximately half as much rescue morphine over the duration of the trial (2.3 doses vs. 4.0 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.

"In addition to the rapid and consistent pain control we observed with Zalviso in this study", stated AcelRx Chief Medical Officer, Pamela Palmer, MD, PhD, "we were particularly encouraged by the outcomes of the ease-of-use questionnaire. It is crucial that healthcare providers feel that Zalviso not only meets the pain management needs of their patients, but that it is easy to use and reliable, which we believe is indicated by the favorable scores that were recorded."