AcelRx Sufentanil NanoTab PCA System (ARX-01) Phase 2 Results Featured in Poster Presentations at the 35th Annual Meeting of the American Society of Regional Anesthesia and Pain to be held in Toronto on April 22-25th.
REDWOOD CITY, Calif., April 20 AcelRx Pharmaceuticals, Inc. announced today that results of its Phase 2 studies evaluating the safety and efficacy of the ARX-01 sublingual Sufentanil NanoTab(TM) PCA System will be featured in three poster presentations at the upcoming 35th Annual Regional Anesthesia Meeting of the American Society of Regional Anesthesia and Pain to be held in Toronto, April 22-25, 2010. On Thursday, April 22nd from 8:30 am - 10:00 am (Session I) at the Sheraton Centre Hotel, results will be presented from a Phase 2 multicenter, randomized, placebo-controlled trial evaluating the safety and efficacy of ARX-01 NanoTabs in 101 patients following unilateral knee replacement surgery under lead investigator Harold Minkowitz, MD of the Memorial Hermann Memorial City Medical Center in Houston, TX. Also presented will be results from a similarly designed Phase 2 study in 92 patients following major abdominal surgery authored by lead investigator Neil Singla, MD from Lotus Clinical Research in Pasadena, CA. In addition, results will be presented from a third Phase 2 open-label study led by David Griffin, MD from the Orthopaedic Center of Vero Beach, FL which evaluated the ARX-01 Sufentanil NanoTab PCA System with respect to overall system functionality, as well as the safety and efficacy, in 30 patients following unilateral knee replacement surgery. The ARX-01 system functioned with no failures in all 30 patients and was given very high ratings by patients for ease of use. All three studies demonstrated that ARX-01 provided safe and effective post-operative analgesia, with patients receiving ARX-01 reporting statistically significant reductions in pain intensity over the 12-hour study period compared to placebo. In addition, the proportion of patients who dropped out due to inadequate analgesia, a clinically meaningful secondary endpoint, was also significantly lower in the ARX-01 groups than in the placebo group. ARX-01 was well tolerated; the most common adverse event reported was mild to moderate nausea with similar incidence between all treatment groups (including placebo). Abstracts are available through the AcelRx Pharmaceuticals web site: http://www.acelrx.com/products/acute-in-hospital-pain/
About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals is a privately held specialty pharmaceutical company dedicated to the development and commercialization of new therapies for the treatment of pain and other conditions where there is an unmet need for improved safety and efficacy. The company applies its proprietary dosage form and delivery technologies to enhance the safety, therapeutic benefit and commercial attractiveness of currently approved compounds. AcelRx pipeline products include: ARX-01, the Sufentanil NanoTab(TM) PCA System, which is a non-invasive, sublingual, patient-controlled analgesia (PCA) system for the treatment of post-operative pain in the hospital setting with significant advantages over intravenous PCA ; ARX-02, a sublingual Sufentanil NanoTab product with fast onset- and fast offset-of-action for the treatment of cancer breakthrough pain (BTP) with significant advantages over current fentanyl-based BTP products; and ARX-03, a sublingual Sufentanil/Triazolam NanoTab product for use in producing mild sedation, anxiolysis and analgesia, with fast onset for office-based diagnostic and therapeutic procedures. For additional information about AcelRx Pharmaceuticals visit http://www.acelrx.com.
SOURCE AcelRx Pharmaceuticals, Inc.
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