New phase III trial announced as part of FDA resubmission for Zalviso (sufentanil sublingual tablet system) in post-operative pain- AcelRx Pharmaceuticals

AcelRx Pharmaceuticals has received comments from the FDA's Division of Anesthesia, Analgesia, and Addiction Products on the Company's proposed protocol for a Phase III clinical study (IAP312) designed to assess the overall performance of Zalviso (sufentanil sublingual tablet system). This follows the company's original submission to the FDA in 2014. AcelRx now plans to initiate the study in the first quarter of 2016. The IAP312 study will include approximately 310 post-operative patients and collect information requested by the Division to supplement the three positive Phase III trials already completed. The planned open-label study will enroll adult postoperative patients who will self-administer 15 mcg sublingual sufentanil using Zalviso for 24-to-72 hours. The study will measure the rate of device errors, including the failure to dispense medication as well as the incidence of misplaced or dropped tablets. Efficacy pain measurements and safety data will also be collected in the study.

The NDA resubmission will include, in addition to the results of bench testing and human factors studies conducted with the modified Zalviso design, the results from the IAP312 study. Prior Phase III trials include two Phase III placebo-controlled studies (IAP310 and IAP311) in which Zalviso demonstrated superiority over placebo in the management of moderate-to-severe acute post-operative pain, as measured by time-weighted SPID48, the primary endpoint. In IAP309, a Phase III active-controlled study, Zalviso was statistically significantly superior in patient global assessment of method of pain control in comparison to intravenous (IV) PCA morphine. The most common adverse events experienced by patients using Zalviso were nausea, pyrexia (fever) and vomiting.