Phase III study of Sufentanil NanoTab PCA System (AcelRx Pharmaceuticals) meets primary endpoint for Pain relief
Top-line data from a Phase III study of Sufentanil NanoTab PCA System, from AcelRx Pharmaceuticals, shows that the primary efficacy endpoint was achieved. The study evaluated control of Pain intensity compared to baseline during the 48-hour study period immediately following major orthopedic surgery, specifically knee or hip replacement, using the FDA-requested primary endpoint of Summed Pain Intensity Difference to baseline (SPID-48). Results demonstrated that patients receiving sufentanil NanoTabs realized a significantly greater SPID-48 during the study period than placebo-treated patients (+76.1 vs -11.5, p<0.001).>
Secondary endpoint data showed that SPID at 24 and 72 hours was also greater in the sufentanil-treated patients. Adverse events reported in the study were generally mild or moderate in nature and were similar in both placebo and treatment groups. Results confirm all previously reported Phase III trial outcomes, supporting submission of an NDA anticipated for third quarter 2013.
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