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AcelRx Pharmaceuticals Reports Third Quarter 2012 Financial Results
Date:11/6/2012

st quarter of 2013.
  • During the third quarter, the U.S. Patent and Trademark Office issued four additional patents covering AcelRx's proprietary NanoTab technology.  AcelRx has now received a total of five U.S. patents underpinning its four product development programs and proprietary NanoTab technology.
  • The European Medicines Agency, or EMA, notified AcelRx that it will permit registration of the Sufentanil NanoTab PCA System via the centralized procedure.  This procedure will allow AcelRx to submit a single Marketing Authorization Application to the EMA for approval to market ARX-01 in all 27 EU member states, as well as in the 4 European Free Trade Association countries.
  • In early November 2012, AcelRx dosed the first patient in a Phase 2 study for ARX-04, its single dose sufentanil NanoTab product candidate for the management of acute pain.  The study is funded by a grant from the USAMRMC and will enroll approximately 100 patients following bunionectomy surgery, randomizing them into one of three groups to receive one of two sufentanil NanoTab dosage amounts (20 mcg and 30 mcg) or placebo.
  • Financial Outlook
    AcelRx anticipates that research and development expenses for the fourth quarter of 2012 and the first half of 2013 will increase as AcelRx conducts and completes the Phase 3 clinical trials for ARX-01.  Development of ARX-04 through Phase 2 clinical work and Phase 3 preparatory work is expected to be fully funded by a grant from USAMRMC.  The development of ARX-04 beyond Phase 2 and initial preparations for Phase 3 is dependent on the identification of additional funding from USAMRMC or other sources.  Additionally, AcelRx anticipates modest increases in general and administrative expenses due to costs associated with expansion of its corporate infrastructure to support ongoing development of its product candidates.

    Conference Call
    AcelRx will conduct a conference call and webca
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    SOURCE AcelRx Pharmaceuticals, Inc.
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