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AcelRx Pharmaceuticals Inc Announces Top-Line Data Demonstrate Primary Endpoint Achieved In Final Pivotal Phase 3 Study Of Sufentanil Nanotab PCA System For Management Of Post-Operative Pain

Tuesday, 21 May 2013 07:30am EDT 

AcelRx Pharmaceuticals Inc announced top-line data demonstrating that in a placebo-controlled Phase 3 study of its investigational sublingual Sufentanil NanoTab PCA (patient-controlled analgesia) System (NanoTab System), 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 (i.e. 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 hours and 72 hours was also significantly greater in the sufentanil-treated patients than in the placebo-treated patients (p <0.001 in each case). Adverse events reported in the study were generally mild or moderate in nature and were similar in both placebo and treatment groups for the majority of adverse events. Utilizing a randomized, double-blind, placebo-controlled design, this pivotal Phase 3 study enrolled 426 adult patients at 34 U.S. sites for treatment of moderate=to-severe acute pain immediately following major orthopedic surgery. Seven patients did not receive study drug, resulting in 419 patients being included in the intent-to-treat (ITT) population. 

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20 Apr 2015