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AcelRx Pharmaceuticals Reports Positive Results From a Phase 2 Clinical Trial of Sublingual Sufentanil NanoTabs(TM) in Treating Post-Operative Pain
Date:12/9/2008

cg or 15mcg of sufentanil. Doses were delivered sublingually as needed to treat pain with a 20-minute minimum re-dosing interval and patients were allowed to drop out of the study at any time. Positive results were also obtained for the primary endpoint following treatment with the 15mcg dose compared to placebo using two alternate methods for imputing missing data from drop-outs: baseline observation carried forward (BOCF), p = 0.007, and last observation carried forward (LOCF), p = 0.018. Importantly, there were no events of clinically significant respiratory depression for any dosing group. Based on these positive results, AcelRx intends to further advance clinical development of ARX-01 in 2009.

"We are pleased by the wonderful clinical results of our Phase 2 post-operative acute pain study," said Thomas A. Schreck, chairman and chief executive officer of AcelRx Pharmaceuticals. "This is the culmination of a great deal of hard work by a team of efficient, dedicated people over the last two years, and is therefore very gratifying indeed. This trial has the benefit of validating Sublingual Sufentanil NanoTabs as a robust product candidate for its initial in-hospital acute pain indication, as well as providing the foundation of safety and efficacy for the other programs in our pipeline."

About ARX-01 Sublingual Sufentanil NanoTabs

Sufentanil is currently approved as an intravenous (IV) anesthetic and is also indicated for epidural administration during labor and delivery. Due to their small size, ARX-01 Sublingual Sufentanil NanoTabs are convenient, well-tolerated, have high bioavailability and provide lower peak plasma levels compared to IV administration.

About the ARX-01 Oral Patient-Controlled Analgesia System

The ARX-01 Oral Patient-Controlled Analgesia (PCA) system is based on a proprietary pre-programmed, hand-held dispenser being developed by AcelRx. The AcelRx d
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SOURCE AcelRx Pharmaceuticals, Inc.
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