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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

REDWOOD CITY, Calif., March 4, 2013 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced top-line data results demonstrating that the first of two pivotal placebo-controlled Phase 3 studies for its investigational sublingual Sufentanil NanoTab PCA (patient-controlled analgesia) System met its primary endpoint.  Adverse events reported in the study were generally mild or moderate in nature and similar in both placebo and treatment groups.

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The primary endpoint evaluated pain intensity over the 48-hour study period compared to baseline, or Summed Pain Intensity Difference (SPID-48), in patients following major open abdominal surgery.  Results demonstrated that patients receiving sufentanil NanoTabs realized a significantly greater SPID-48 during the study period than placebo-treated patients (p=0.001).  Secondary endpoint data also showed that 24 hours and 72 hours after first dose, SPID was significantly greater in the sufentanil-treated patients than in the placebo-treated patients (p<0.001 and p=0.004 respectively).     

"These favorable results enable AcelRx to continue moving forward towards submission of a New Drug Application (NDA) for the Sufentanil NanoTab PCA System in the third quarter of this year," said Richard King , president and CEO of AcelRx.  "In the weeks ahead, our team will work with the FDA to complete a pre-NDA meeting in support of this goal."

Phase 3 Study Results
Utilizing a randomized, double-blind, placeb
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SOURCE AcelRx Pharmaceuticals, Inc.
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