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AcelRx Pharmaceuticals Reports First Quarter 2013 Financial Results
Date:5/8/2013

l trials for the NanoTab System.
This trial involved 178 adult patients recruited at 13 U.S. sites following major open abdominal surgery, and focused on the management of acute pain for up to 72 hours after the first study dose was given shortly after completion of surgery.  The primary endpoint for this trial was the time weighted summed pain intensity difference to baseline over 48 hours, or SPID-48.  The top-line data demonstrated that patients receiving sufentanil NanoTabs realized a significantly greater SPID-48 (pain reduction) during the study period than placebo-treated patients (p=0.001).  Secondary endpoint data also showed that 24 and 72 hours after first dose, the SPID was significantly greater in the sufentanil-treated patients than in the placebo-treated patients (p<0.001 and p=0.004, respectively).  Sufentanil NanoTab treatment in this study was well tolerated, with the rate of adverse events being similar in both the active and placebo groups. Itching, a frequently observed side effect of opioids was the only adverse event that was significantly different between the two treatment arms, being seen more frequently in sufentanil-treated patients than placebo-treated patients.  Adverse events were generally mild-to-moderate in nature. 
  • During the first week of April 2013, AcelRx completed enrollment in a second and final Sufentanil NanoTab PCA System pivotal Phase 3 trial, with approximately 420 patients randomized 3:1 (active:placebo) in a  double-blind, placebo-controlled efficacy and safety clinical trial in adults immediately following major orthopedic surgery.  Top-line results should be available in the second quarter 2013.  The primary endpoint for the orthopedic Phase 3 study is SPID-48.  
  • On April 24, 2013, AcelRx announced positive top-line results in a Phase 2 double-blind, placebo-controlled, dose-finding trial for ARX-04, a single-dose, sufentanil NanoTab product c
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  • SOURCE AcelRx Pharmaceuticals, Inc.
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