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AcelRx Announces Initiation of Phase 3 Clinical Program for ARX-01, the Sufentanil NanoTab® PCA System for the Treatment of Post-Operative Pain
Date:3/6/2012

hed data on IV PCA side-effect profiles suggests that somnolence (~50% of patients) and oxygen desaturation (~10% of patients) is unacceptably high.  In our Phase 2 clinical studies, patients dosing over 12 hours with Sufentanil NanoTabs (15 mcg) exhibited a low incidence of somnolence (3%) and oxygen desaturation (1%).
  • A non-invasive route of delivery: The sublingual route of delivery used in ARX-01 provides rapid onset of analgesia, therefore eliminating the risk of IV-related analgesic gaps and IV complications, such as catheter-related infections.  In addition, because patients are not tethered to IV tubing and a pump for pain relief, ARX-01 allows for ease of patient mobility.
  • A simple, pre-programmed PCA solution: ARX-01 is a preprogrammed PCA System designed to eliminate the risk of pump programming errors, which are a potential source of patient harm. 

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    About AcelRx Pharmaceuticals, Inc.
    Based in Redwood City, CA, AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain.  AcelRx's lead product candidate, the ARX-01 Sufentanil NanoTab PCA System, which is currently in Phase 3 clinical development, is designed to solve the problems associated with post-operative intravenous patient-controlled analgesia which has been shown to cause harm to patients following surgery because of the side effects of morphine, the invasive IV route of delivery and the inherent potential for programming and delivery errors associated with the complexity of infusion pumps.  AcelRx has two additional product candidates which have completed Phase 2 clinical development: ARX-02 for the treatment of cancer breakthrough pain, and ARX-03 for providing mi
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