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AcelRx Announces Positive Phase 2 Results from a Study of ARX-01 Sufentanil NanoTabs in Treating Post-Operative Pain
Date:6/29/2009

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Study investigator, anesthesiologist Dr. Neil Singla, CEO of Lotus Clinical Research Inc., Pasadena, CA, stated, "The ARX-01 product has the potential to offer a major advance in the management of inpatient acute pain, liberating patients from the IV connection to a PCA pump, while still providing effective pain control appropriate even for patients who are restricted from oral medication. Patients appear to tolerate the Sufentanil NanoTabs well, and following the end of the 12-hour study period when they were switched to IV PCA morphine, many requested that they be returned to study drug. To me, these patients' requests are as demonstrative as any more quantitative endpoint of the product's advantages from the patient perspective."

The current data support the previously reported positive results for ARX-01 from the first Phase 2 study which evaluated the safety and efficacy of ARX-01 Sufentanil NanoTabs in patients undergoing elective unilateral knee replacement surgery. Additionally, an open-label Phase 2 study is currently ongoing with the primary objective of assessing the functionality of the handheld device component of the ARX-01 Sufentanil NanoTab PCA System in patients undergoing unilateral knee replacement surgery.

AcelRx Chief Medical Officer, Pamela Palmer, M.D., Ph.D., commented, "The Phase 2 results from both knee replacement and major abdominal surgery studies demonstrate that a wide variety of patients experiencing moderate-to-severe post-operative pain are able to achieve significant pain relief with our non-invasive approach to patient-controlled analgesia utilizing sublingual Sufentanil NanoTabs. We are pleased with the efficacy results, as well as with the overall side-effect profile of ARX-01 which was indistinguishable from placebo in both studies."

About Acute Post-Operative Pain

Annually, approximately 8 million patients in the U.S. receive intravenous (IV) patient-cont
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SOURCE AcelRx Pharmaceuticals, Inc.
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