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Top-line Data Show AcelRx Pharmaceuticals' ARX-04 Achieves Primary Endpoint in Dose-Finding Phase 2 Clinical Trial
Date:4/24/2013

eneral for patients in moderate-to-severe acute pain where intravenous access is not readily available."

This study randomized 101 patients following bunionectomy surgery in a 2:2:1 ratio to 30 mcg sufentanil, 20 mcg sufentanil or placebo treatment arms.  The intent-to-treat (ITT) population in this study averaged 42.5 years of age with an average Body Mass Index of 28.2, and was evenly balanced for males and females (51%:49%) and ethnicity (54% Caucasian:46% non-Caucasian).  Ninety-one percent of patients entering the study completed the full 12-hour study period.  SPID-12 scores were +6.53 for 30 mcg sufentanil-treated patients and -7.12 for placebo-treated patients, the difference between the two groups being highly statistically significant (p=0.003).  The 20 mcg sufentanil-treated patients did not achieve SPID-12 scores that differentiated from placebo.

"The results from this study, funded by the U.S. Army Medical Research and Materiel Command, provide further validation of our sufentanil NanoTab product platform as an effective treatment for moderate-to-severe acute pain," said Richard King , president and CEO of AcelRx. "AcelRx will present these positive top-line data to USAMRMC, and intends to hold an End of Phase 2 meeting with the FDA to define the Phase 3 clinical program for ARX-04."

About ARX-04

ARX-04 is a product candidate in development for the treatment of moderate-to-severe acute pain, consisting of sufentanil, a high therapeutic index opioid, in AcelRx's proprietary NanoTab technology that enables rapid sublingual absorption when the NanoTab is placed under the tongue.  As a result, sufentanil NanoTabs are designed to provide rapid onset of analgesia in a non-invasive method of administration and display a consistent pharmacokinetic profile due to a high percentage of drug being absorbed sublingually instead of through the gastrointestinal tract.  We believe
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SOURCE AcelRx Pharmaceuticals, Inc.
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