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AcelRx Pharmaceuticals Reports Positive Results from a Clinical Trial of Sublingual Sufentanil/Triazolam NanoTab(TM) Combination (ARX-03) in Treating Procedural Pain and Anxiety
Date:1/12/2009

Results Show Successful Clinical Validation of Pharmacodynamic Effect

REDWOOD CITY, Calif., Jan. 12 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc., an emerging specialty pharmaceutical company focused on the treatment of intermittent and acute medical conditions with an initial emphasis on pain management, today announced positive results from a Phase 1 clinical study evaluating the safety, tolerability and efficacy of the company's proprietary sublingual sufentanil (opioid) and triazolam (benzodiazepine) NanoTab(TM) combination product candidate (ARX-03). The product is designed to address the current unmet need for a non-invasive product to provide sedation and analgesia for an increasing number of office-based procedures.

The study demonstrated that administration of ARX-03 resulted in a statistically significant increase in sedation levels for the 10mcg sufentanil/200mcg triazolam dosage strength in both a younger cohort (age range 18-60 years; p=0.009) and an older cohort (age range of 61-80 years; p=0.003) as compared to sublingual sufentanil alone. These data were collected using the Richmond Agitation-Sedation Scale (RASS), a validated and objective test for assessment of sedation levels. The average onset of sedation was 20-30 minutes for the higher dosage strength in each study cohort.

Additionally, sublingual administration of the sufentanil/triazolam combination was found to be safe and well tolerated. Based on these positive results, AcelRx intends to further advance clinical development of ARX-03 in 2009.

"We believe the results of this trial are particularly valuable as they offer clinical evidence well beyond what is expected from a typical Phase 1 study. Not only have we shown ARX-03 to be safe and well-tolerated, we have also demonstrated significant pharmacodynamic findings with a randomized, double-blind design that spanned different age groups and multiple dosage level
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SOURCE AcelRx Pharmaceuticals, Inc.
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