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AcelRx Pharmaceuticals Provides Clinical Trial Updates
Date:2/19/2013

he study is designed to assess the ability of sufentanil, delivered through the NanoTab System to control moderate-to-severe post-operative pain over 48 to 72 hours compared to a placebo delivered through the NanoTab System.  The study will also assess the tolerability, safety, and ease of use of the NanoTab System by nurses and patients.  Top-line results are expected in the first quarter of 2013. 
  • A second placebo-controlled Phase 3 trial with the Sufentanil NanoTab PCA System is being conducted at approximately 32 sites in patients following hip or knee replacement surgery.   Targeting enrollment of approximately 400 patients, dosing of the final subject in this study is expected around the end of the first quarter of 2013.  The primary endpoint for both the abdominal and orthopedic placebo-controlled Phase 3 studies is the sum of pain intensity difference to baseline (SPID) over 48 hours. Top-line results should be available for the orthopedic study during the second quarter of 2013.
  • Dosing of the last patient in a Phase 2, placebo-controlled, dose-finding study of the Company's ARX-04 sufentanil NanoTab product has completed.  This study, which began in November 2012, enrolled 101 patients following bunionectomy surgery, randomized into one of three groups: 20 mcg sufentanil NanoTab, 30 mcg sufentanil NanoTab or placebo.  Each dose was administered by healthcare personnel, as requested by the patient, up to a maximum of one dose every hour.  The study is designed to evaluate the ability of sufentanil NanoTabs to manage moderate-to-severe acute pain over the first 12 hours following bunionectomy surgery.  ARX-04 is a sublingual sufentanil product candidate designed to provide a non-invasive, fast-onset treatment of patients with moderate-to-sever acute pain, both on the battlefield and in civilian settings of trauma or injury.  AcelRx is conducting the study at two sites with funding
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