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AcelRx Announces Perfect Performance of Handheld Component of ARX-01 Sufentanil NanoTab PCA System in a Phase 2 Study
Date:7/22/2009

s device functionality study, AcelRx has conducted two placebo-controlled Phase 2 studies of ARX-01 Sufentanil NanoTabs in patients undergoing elective unilateral knee replacement surgery and in patients undergoing major abdominal surgery. Both of those studies demonstrated highly significant efficacy results for the 15 mcg dose relative to placebo in reducing pain intensity over the 12-hour study periods.

About Acute Post-Operative Pain

Annually, approximately 8 million patients in the U.S. receive intravenous (IV) patient-controlled analgesia (PCA), typically utilizing morphine, for inpatient post-operative pain, with a similar number in the E.U. Despite its widespread use, the IV PCA architecture has several limitations. The IV line tethering the patient to the PCA pump discourages mobility, which is a critical factor in preventing post-operative complications and advancing recovery. Furthermore, the invasive nature of the IV delivery mode poses infection risk as well as predisposition to analgesic gaps due to infiltrated and dislodged IV catheters. Additionally, the complexity and programmability of IV PCA pumps introduce opportunities for medication errors, which in some instances may be fatal.

About ARX-01 Sufentanil NanoTab PCA System

ARX-01 is a novel drug/device combination product candidate designed for use in hospital settings to provide non-invasive patient-controlled analgesia and maximize patient satisfaction with post-operative pain management. The ARX-01 Sufentanil NanoTab PCA System avoids many of the limitations of IV PCA approaches by providing a non-invasive, pre-programmed, handheld PCA solution. The handheld component of ARX-01 allows for convenient patient selfadministration of sufentanil NanoTabs sublingually for oral transmucosal absorption. Sufentanil is a high therapeutic index opioid approved for IV and epidural administration. Although the analgesic efficacy of s
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SOURCE AcelRx Pharmaceuticals, Inc.
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