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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

REDWOOD CITY, Calif., Dec. 9 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. today announced positive results from a Phase 2 clinical study evaluating the safety and efficacy of its lead product candidate, ARX-01, for the treatment of moderate-to-severe inpatient acute pain following knee replacement surgery. The primary endpoint evaluated pain intensity (Sum of the Pain Intensity Difference - SPID12) over the 12-hour study period compared to baseline. Results demonstrated that compared to placebo, patients receiving 15 mcg of ARX-01 experienced a statistically significant reduction in pain intensity over the study period, based on the worst observation carried forward imputation method (WOCF), p=0.015. Additionally, at the 15 mcg dose, the study met an important secondary endpoint compared to placebo, the percentage of patient dropouts due to inadequate analgesia, p=0.006. Further, no serious or unexpected adverse events related to ARX-01 were reported in the study.

ARX-01 is a sublingual formulation of the opioid pain medication, sufentanil. ARX-01 is based on the company's proprietary NanoTab(TM) dosage form, which enables delivery of sufentanil by the non-invasive oral transmucosal (sublingual) route.

"We chose a very painful surgery in an elderly patient population to showcase the efficacy and safety of Sublingual Sufentanil NanoTabs in treating acute post-operative pain," said Pamela Palmer, M.D., Ph.D., chief medical officer of AcelRx Pharmaceuticals. "The superior attributes of both the drug and the dosage form enabled these highly encouraging Phase 2 results."

This multicenter, double-blind, randomized, placebo-controlled, dose-finding Phase 2 study evaluated the safety and efficacy of ARX-01 in patients undergoing elective unilateral knee replacement surgery. In the study, 101 patients were randomized to receive either placebo or one of three different dosage strengths of ARX-01: 5mcg, 10m
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SOURCE AcelRx Pharmaceuticals, Inc.
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