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Top-line Data Demonstrate Primary Endpoint Achieved in Final Pivotal Phase 3 Study of Sufentanil NanoTab PCA System For Management of Post-Operative Pain
Date:5/21/2013

REDWOOD CITY, Calif., May 21, 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 demonstrating that in a placebo-controlled Phase 3 study of its investigational sublingual Sufentanil NanoTab PCA (patient-controlled analgesia) System (NanoTab System), the primary efficacy endpoint was achieved.  The study evaluated control of pain intensity compared to baseline during the 48-hour study period immediately following major orthopedic surgery, specifically knee or hip replacement, using the FDA-requested primary endpoint of Summed Pain Intensity Difference to baseline (i.e. SPID-48).  Results demonstrated that patients receiving sufentanil NanoTabs realized a significantly greater SPID-48 during the study period than placebo-treated patients (+76.1 vs -11.5, p<0.001).  Secondary endpoint data  showed that SPID at 24 hours and 72 hours was also significantly greater in the sufentanil-treated patients than in the placebo-treated patients (p<0.001 in each case).
Adverse events reported in the study were generally mild or moderate in nature and were similar in both placebo and treatment groups for the majority of adverse events.

"With the successful completion of this study, AcelRx has now achieved positive results in all three Phase 3 studies in which the Sufentanil NanoTab PCA System has been evaluated," said Richard King , president and CEO of AcelRx.  "We remain on track for a third quarter 2013 NDA submission for the NanoTab System, a product which, if approved, will present AcelRx with an opportunity to fundamentally redefine the management of post-operative pain for tens of millions of
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SOURCE AcelRx Pharmaceuticals, Inc.
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