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AcelRx Pharmaceuticals Reports Third Quarter 2012 Financial Results
Date:11/6/2012

30, 2012 and $35.8 million at December 31, 2011.

"We continue to make progress in the execution of our Phase 3 program for ARX-01.  During the third quarter, we initiated our third Phase 3 clinical trial, received four additional U.S. patents related to our sufentanil NanoTab technology and we were notified that ARX-01 was deemed sufficiently novel that we would be allowed to use the centralized filing procedure for ARX-01 in Europe," stated Richard King, president and CEO of AcelRx. "In addition, we completed treatment of the final subject in our Phase 3 clinical trial comparing ARX-01 to IV PCA with morphine.  We expect to announce top line data from this first trial later this month and results from our two other ARX-01 trials is expected in the first quarter of 2013."

Review of Third Quarter Accomplishments and Corporate Update

  • In August 2012, AcelRx initiated the third of three planned Phase 3 clinical trials for ARX-01, a double-blind, placebo-controlled efficacy and safety trial in adult patients with post-operative pain following hip or knee replacement surgery.  This study is designed to enroll approximately 400 patients and is being conducted at approximately 45 academic and community hospitals in the U.S.  The primary endpoint is the sum of the pain intensity difference to baseline, over the 48 hour study period, or SPID-48, which is the FDA standard for post-operative acute pain studies.
  • Dosing of the last patient in the Phase 3 open label, active comparator study comparing efficacy and safety of the Sufentanil NanoTab System to the commonly used IV PCA with morphine is complete, and top line data are expected in November, 2012.  Top line results from the two placebo-controlled Phase 3 clinical studies, one treating post-operative pain in patients following abdominal surgery and the other treating post-operative pain in patients following hip or knee replacement, are both expected during the fir
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  • SOURCE AcelRx Pharmaceuticals, Inc.
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