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AcelRx Announces Its ARX-01 Phase 3 Program Expected To Start Late Q1 Or Early Q2 2012

  

REDWOOD CITY, Calif., Jan. 31, 2012 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), ("AcelRx"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, reported that the two remaining items required by the FDA prior to the initiation of the Phase 3 clinical program for ARX-01, specifically software verification and validation of the ARX-01 system, are progressing.  AcelRx believes that dosing of the first patient in the first ARX-01 Phase 3 study should occur either late Q1 or early Q2 2012.  The ARX-01 Phase 3 program is comprised of three studies – a placebo-controlled post-operative pain study following major abdominal surgery, a placebo-controlled study in patients after major orthopedic surgery and an active comparator study comparing the Sufentanil NanoTab PCA System to intravenous morphine patient-controlled analgesia in post-operative patients.

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 in preparation for 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 mild sedation, anxiety reduction and pain relief for patients undergoing painful procedures in a physician's office.  A fourth product candidate, ARX-04, is a sufentanil product for the treatment of moderate-to-severe acute pain that is expected to enter Phase 2 clinical development in the first quarter of 2012 under a grant from the US Army Medical Research and Material Command, or USAMRMC.

Forward Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related to the planned or anticipated future clinical development of AcelRx Pharmaceuticals' ARX-01 product candidate, including the expected initiation of its Phase 3 studies for ARX-01, the timing thereof and events related thereto, and the therapeutic and commercial potential of AcelRx Pharmaceuticals' product candidates.  These forward-looking statements are based on AcelRx Pharmaceuticals' current expectations and inherently involve significant risks and uncertainties.  AcelRx Pharmaceuticals' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to: the success, cost and timing of AcelRx Pharmaceuticals' product development activities and clinical trials; the uncertain clinical development process, including the risk that the Phase 3 clinical trials may not begin on time, have an effective design, enroll a sufficient number of patients, or be initiated or completed on schedule, if at all; the uncertainty of the FDA's regulatory process, including uncertainty as to whether AcelRx Pharmaceuticals will be able to complete the software verification and software validation activities required to initiate the first Phase 3 clinical study for ARX-01; its ability to obtain adequate clinical supplies of the drug and device components of its product candidates, including ARX-01; its ability to attract funding partners or collaborators with development, regulatory and commercialization expertise; its ability to obtain sufficient financing to complete development and registration of its product candidates in the United States and Europe; the accuracy of AcelRx Pharmaceuticals' estimates regarding expenses, capital requirements and needs for financing; and other risks detailed in the "Risk Factors" and elsewhere in AcelRx Pharmaceuticals' U.S. Securities and Exchange Commission filings and reports, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2011.  AcelRx Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.

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