AcelRx (Nasdaq: ACRX) Announces its ARX-01 Phase 3 Program Expected to Start Late Q1 or Early Q2 2012

Orlando, FL 1/31/12 (StreetBeat) -- AcelRxPharmaceuticals, Inc. (Nasdaq: ACRX), 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 additionalproduct 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.

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