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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

REDWOOD CITY, Calif., July 22 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. today announced positive results from its first Phase 2 clinical study evaluating the functionality of the handheld device component of its ARX-01 Sufentanil NanoTab(TM) PCA System for management of acute post-operative pain in patients requiring opioid analgesia during hospitalization. Patients reliably self-administered sufentanil NanoTabs repeatedly over the 12-hour study without any ARX-01 System failures or dosing errors of any kind.

This multicenter, open-label study included 30 patients (median age 68; range 51-74) undergoing elective unilateral knee replacement surgery. Patients self-administered 15 mcg doses of ARX-01 Sufentanil NanoTabs sublingually as needed using the ARX-01 handheld, with a minimal re-dosing interval of 20 minutes. The primary endpoint was device functionality assessed as the proportion of patients who successfully completed the study without any type of System failure. There were no System failures or dosing errors of any kind throughout the study, which included over 375 dispensed NanoTabs. Additionally, preliminary analysis of efficacy results indicated a dropout rate due to inadequate analgesia of less than 10%, consistent with the superior efficacy reported for the 15 mcg dose in two earlier Phase 2 placebo-controlled studies. ARX-01 was well-tolerated, and there were no serious adverse events related to study drug.

AcelRx Chief Engineering Officer, Anil Dasu, commented, "These results confirm the simple usability and consistent functionality of the handheld component of the ARX-01 Sufentanil NanoTab PCA System in the hands of post-surgical patients. Not only have the patients been pleased with the ease of use of the ARX-01 System, but the medical staff has also been highly satisfied with System's ease and speed of set-up and reliability."

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