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AcelRx Pharmaceuticals Reports Fourth Quarter and Full-Year 2011 Financial Results
Date:3/20/2012

lacebo-controlled efficacy and safety trial in adults following open abdominal surgery.  Approximately 150 adults, randomized 2:1 to active or placebo treatment groups, will be treated for post-operative pain for 48 - 72 hours after randomization.  
  • A second Phase 3 study is planned as an open-label, active-comparator study comparing ARX-01 to the current standard of care, intravenous patient-controlled analgesia, with morphine. The primary endpoint for this study will assess a measure of efficacy, Global Patient Satisfaction over the 48-hour study period, and will compare ratings of "Good" and "Excellent" for Global Patient Satisfaction between the two groups in a non-inferiority comparison.
  • The third and final planned Phase 3 clinical study is a randomized, double-blind, placebo-controlled efficacy and safety study comparing ARX-01 to placebo for post-operative pain control following major joint replacement surgery.

  • Financial OutlookAcelRx anticipates that research and development expenses will increase significantly over the next several quarters as AcelRx seeks to complete Phase 3 clinical development of ARX-01. The development of ARX-04 beyond Phase 2 and initial preparations for Phase 3 are dependent on the identification of sources of additional funding from the USAMRMC or the identification of a partner to support these efforts.  Additionally, AcelRx anticipates modest increases in general and administrative expenses due to costs associated with operating as a public company and expansion of its corporate infrastructure to support ongoing development of its product candidates.

    AcelRx believes its current cash, cash equivalents and investments are sufficient to fund operations into the first quarter of 2013.

    About AcelRx Pharmaceuticals, Inc. Based in Redwood City, CA, AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) i
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    SOURCE AcelRx Pharmaceuticals, Inc.
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    Related medicine technology :

    1. AcelRx Pharmaceuticals Reports Positive Results from a Clinical Trial of Sublingual Sufentanil/Triazolam NanoTab(TM) Combination (ARX-03) in Treating Procedural Pain and Anxiety
    2. AcelRx Initiates a Phase 2 Study to Evaluate Functionality of Its ARX-01 Sufentanil NanoTab PCA System
    3. AcelRx Announces Positive Phase 2 Results from a Study of ARX-01 Sufentanil NanoTabs in Treating Post-Operative Pain
    4. AcelRx Programs to be Featured in Oral Presentations at the American Society of Anesthesiologists 2009 Annual Meeting
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    6. AcelRx Announces Positive Phase 2 Results From a Study of ARX-02 Sufentanil NanoTab(TM) Breakthrough Pain Management System in Treating Cancer Breakthrough Pain
    7. AcelRx Pharmaceuticals Files Registration Statement for Proposed Initial Public Offering
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    10. AcelRx Pharmaceuticals Reports Fourth Quarter and Full-Year 2010 Financial Results
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