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AcelRx Announces Positive Phase 2 Results From a Study of ARX-02 Sufentanil NanoTab(TM) Breakthrough Pain Management System in Treating Cancer Breakthrough Pain
Date:5/25/2010

esic efficacy in this patient population. For example, the time-weighted Total Pain Relief (TOTPAR) for ARX-02 separated from placebo at 10 minutes (p = 0.049), the earliest time point recorded. In addition, there was no statistical difference in the frequency of any class of adverse events between ARX-02 and placebo treatments.

Pamela Palmer, MD, PhD, AcelRx Chief Medical Officer stated, "Sufentanil, the active agent in ARX-02, is a highly lipophilic drug with rapid transit time to the brain effector sites. The early onset of analgesia demonstrated by significant pain relief as early as 10 minutes in this study suggests that ARX-02 is ideal for the indication of breakthrough pain. In addition, the shorter plasma half-life seen with ARX-02 more closely matches effective opioid levels to the duration of a breakthrough pain event compared to commercially available fentanyl-based breakthrough pain products."

About Cancer Breakthrough Pain

Many patients with cancer-related pain are treated chronically with pain medication, but still experience episodes of severe pain that "breaks through" this base level of pain control. Typically the pain flare occurs with rapid onset and lasts approximately 15-60 minutes. Patients may experience several of these breakthrough pain episodes per day. Currently, oral transmucosal fentanyl-based products are the only approved treatments for cancer breakthrough pain. These products have prolonged plasma half-lives that extend well beyond four hours for most dosage strengths and due to their varying pharmacokinetics, patients may experience variable onset of analgesia.

About ARX-02

AcelRx is developing ARX-02, a novel sublingual Sufentanil NanoTab product candidate, as a new treatment option for patients with cancer breakthrough pain. Sufen
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SOURCE AcelRx Pharmaceuticals, Inc.
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