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AcelRx Top-line Data Show Primary Endpoint Achieved in Pivotal Phase 3 Study of Sufentanil NanoTab PCA System For Post-Operative Pain in Major Open Abdominal Surgery Patients
Date:3/4/2013

vent that was significantly different between the groups (p=0.017).  All reported cases of itching in the study were mild in nature.   Only one patient (in the sufentanil group) experienced a serious adverse event, which was determined to be unrelated to the study drug by the investigator.   

"These efficacy and safety results underscore the impact of the Sufentanil NanoTab PCA System by potentially providing medical professionals a non-invasive method to help relieve moderate-to-severe post-operative pain in patients undergoing major surgical procedures, such as open abdominal surgery," commented Pamela Palmer M.D ., Ph.D., chief medical officer and AcelRx co-founder.  "We look forward to completing the full analysis of these data and working with the FDA on the NDA for this important post-operative pain advancement."

"The positive results to date for this, non-invasive approach for the management of moderate-to-severe post-operative pain are intriguing and I look forward to the complete study results for the entirety of this Phase 3 program," stated study investigator Dr. Tong- Joo Gan , Vice-Chair of the Department of Anesthesiology at Duke University School of Medicine, Durham, N.C.

One additional pivotal Phase 3 double-blind, placebo-controlled study of the Sufentanil NanoTab PCA System is underway.  The study began in August 2012, and is designed to enroll approximately 400 patients in a 3:1 randomization following hip or knee replacement surgery at up to 35 sites. The primary endpoint, SPID-48, is identical to the primary endpoint for the abdominal surgery trial.  We expect top-line results for this trial to be available in the second quarter of 2013.  Additional information can be found by visiting www.ClinicalTrials.gov and using the identifier NCT016607
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SOURCE AcelRx Pharmaceuticals, Inc.
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