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Top-line Data Show AcelRx Pharmaceuticals' ARX-04 Achieves Primary Endpoint In Dose-Finding Phase 2 Clinical Trial

REDWOOD CITY, Calif., April 24, 2013 /PRNewswire/ --- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced top-line results demonstrating that a placebo-controlled, dose-finding, Phase 2 study of its investigational single-dose sublingual sufentanil NanoTab for acute pain, ARX-04, successfully met its primary endpoint.  Results demonstrated that patients receiving 30 mcg sufentanil NanoTab doses, administered by a healthcare professional, no more frequently than once per hour, had significantly greater pain reduction as measured by Summed Pain Intensity Difference to baseline during the 12-hour study period (SPID-12) than placebo-treated patients (p=0.003).  Adverse events reported in the study were generally mild-to-moderate in nature, with two serious adverse events of post-surgical infection reported, both of which were determined by the investigator to be unrelated to study drug.  Two patients dropped out of the study due to adverse events, one patient's discontinuation considered unrelated to study drug, and the other considered probably related to study drug, both in the 30 mcg-treated group.

"The goal of this program, to find an effective sublingual sufentanil dose that could be administered less frequently by a healthcare professional than our patient-administered ARX-01 product candidate, has been met", said Dr. Pamela Palmer, Chief Medical Officer, AcelRx Pharmaceuticals.  "There is a need for a non-invasive, rapid-onset strong analgesic to provide short-term treatment of pain for the wounded soldier on the battlefield, the trauma victim at the site of a road-traffic accident, the migraine patient in the emergency room, or in general for patients in moderate-to-severe acute pain where intravenous access is not readily available."

This study randomized 101 patients following bunionectomy surgery in a 2:2:1 ratio to 30 mcg sufentanil, 20 mcg sufentanil or placebo treatment arms.  The intent-to-treat (ITT) population in this study averaged 42.5 years of age with an average Body Mass Index of 28.2, and was evenly balanced for males and females (51%:49%) and ethnicity (54% Caucasian:46% non-Caucasian).  Ninety-one percent of patients entering the study completed the full 12-hour study period.  SPID-12 scores were +6.53 for 30 mcg sufentanil-treated patients and -7.12 for placebo-treated patients, the difference between the two groups being highly statistically significant (p=0.003).  The 20 mcg sufentanil-treated patients did not achieve SPID-12 scores that differentiated from placebo.

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