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AcelRx Top-line Data Show Primary Endpoint Achieved in Pivotal Phase 3 Study of Sufentanil NanoTab PCA System For Post-Operative Pain in Major Open Abdominal Surgery Patients
Date:3/4/2013

hase 3 clinical trials and a New Drug Application submission is planned for the third quarter of 2013. AcelRx recently completed enrollment in a Phase 2 study for ARX-04, a sufentanil formulation for the treatment of moderate-to-severe acute pain, funded through a grant from U.S. Army Medical Research and Materiel Command, and top-line results are expected in the second quarter of 2013.  The company has two additional pain treatment product candidates, ARX-02 and ARX-03, which have completed Phase 2 clinical development.  For additional information about AcelRx's clinical programs please visit www.acelrx.com.

Forward Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the process and timing of anticipated future clinical development of AcelRx Pharmaceuticals' product candidates, including the release of sufentanil NanoTab PCA System top-line clinical trial data, the release and anticipated timing of additional NanoTab System clinical trial data, the potential submission of an NDA for NanoTab System and the timing thereof, therapeutic and commercial potential of NanoTab System and the anticipated timing and therapeutic and commercial potential of other AcelRx Pharmaceuticals' product candidates.  These forward-looking statements are based on AcelRx Pharmaceuticals' current expectations and inherently involve significant risks and uncertainties.  AcelRx Pharmaceuticals' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to: the ability of AcelRx Pharmaceuticals to successfully complete the clinical trials for the sufentanil NanoTab System, that fact that subsequent analyses of the top-line data may lead to different (including less favorable) interpretations of t
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SOURCE AcelRx Pharmaceuticals, Inc.
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7. AcelRx Announces Achievement of the Primary End-Point in Phase 3 Comparative Study Involving the Sufentanil NanoTab PCA System and Plans to Hold a Conference Call and Webcast Tomorrow to Discuss Top-Line Results
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10. AcelRx Pharmaceuticals to Hold Third Quarter 2012 Financial Results Conference Call and Webcast on November 6, 2012
11. AcelRx Pharmaceuticals Hires Mike A. Royal, M.D. as Chief, Clinical Affairs
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