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

andidate for the management of acute pain in ambulatory settings.  The trial enrolled 101 patients following bunionectomy surgery, randomizing them into one of three groups (20 mcg or 30 mcg sufentanil NanoTab or placebo NanoTab), dosed no more frequently than once per hour.  The study achieved its objective in identifying the 30 mcg dose as the effective dose for sufentanil NanoTabs when dosed once per hour. Patients treated with 30 mcg sufentanil NanoTabs administered by a healthcare professional had significantly greater pain reduction than patients treated with placebo NanoTabs as measured by the summed pain intensity difference to baseline during the 12-hour study period (p=0.003).  Patients treated with 20 mcg sufentanil NanoTabs did not achieve statistically significant separation from placebo.  Adverse events were generally mild-to-moderate in nature, with two serious adverse events occurring, both being judged unrelated to study drug.  Two patients dropped out of the study due to adverse events, one deemed unrelated to study drug and the other considered probably related to study drug. The clinical study and associated research activities for ARX-04 are funded by a grant from USAMRMC.
  • On May 2, 2013 AcelRx presented five posters on the Sufentanil NanoTab PCA System at the American Society of Regional Anesthesia and Pain Medicine (ASRA) annual meeting in Boston.  In one of these posters, new analyses from the Phase 3 trial comparing the NanoTab System to intravenous patient-controlled analgesia (IV PCA) with morphine demonstrated the NanoTab System had a significantly faster reduction in pain intensity compared to IV PCA morphine (p<0.01).  In addition, fewer patients experienced oxygen desaturation events below 95% in the NanoTab System-treated group than in the IV PCA morphine-treated group (p=0.028).  Overall adverse events were similar between groups, and most were mild-to-
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  • SOURCE AcelRx Pharmaceuticals, Inc.
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