In March 2012, AcelRx began its first Phase 3 clinical study for ARX-01, a randomized, double-blind, placebo-controlled efficacy and safety study for post-operative pain following major open abdominal surgery designed to enroll 150 patients. The primary endpoint for this study is SPID-48. In April 2012, the second Phase 3 clinical study for ARX-01 began. It is a randomized, multicenter, open-label, parallel group design that compares the efficacy and safety of the Sufentanil NanoTab PCA System to the standard of care, IV PCA with morphine, in the treatment of post-operative pain associated with major abdominal or orthopedic surgeries. The primary objective of the study, which is expected to enroll approximately 400 patients, is to compare ARX-01 to IV PCA with morphine in terms of patient global satisfaction with the method of pain relief. Patients in each of these two studies will be treated for a minimum of 48 hours after randomization and topline results for both clinical trials are expected during the fourth quarter of 2012.
About Post-Operative Pain
Acute pain management in the hospital, in particular post-operative analgesia, remains a challenge for healthcare providers with up to 75% of patients reporting inadequate pain relief after surgery. Inadequate treatment of post-surgical pain can lead to decreased mobility, which increases the risks for medical complications, including deep vein thrombosis and partial lung collapse, potentially resulting in extended hospital stays. Over 23 million procedures per year result in moderate to severe post-operative pain in the major pharmaceutical markets (U.S., 5 main EU countries and
), resulting in
of acute pain treatment product sales in 2008.
About ARX-01, the Sufentanil NanoTab PCA System
ARX-01 is a pre-programmed, non-invasive, handheld system that allows post-operative patients to self-dose with sublingual Sufentanil NanoTabs to manage their post-operative pain. The ARX-01 System is designed to address the limitations of the current standard of care, IV PCA with morphine, by offering:
About AcelRx Pharmaceuticals, Inc.
- A high therapeutic index opioid : Because ARX-01 uses the high therapeutic index opioid sufentanil, it offers post-operative pain patients the potential for effective patient-controlled analgesia with a low incidence of drug-related side effects.
- 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 pre-programmed PCA System designed to eliminate the risk of pump programming errors, which are a potential source of patient harm.
AcelRx Pharmaceuticals, Inc. 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 mild sedation, anxiety reduction and pain relief for patients undergoing painful procedures in a physician's office. AcelRx plans to initiate a Phase 2 study, pending protocol approval, for a fourth product candidate, ARX-04, a sufentanil formulation for the treatment of moderate-to-severe acute pain, funded through a grant from USAMRMC. For additional information about AcelRx's clinical programs please visit
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' product candidates, including the anticipated timing for clinical trials, progress towards initiation of the Phase 2 study for ARX-04, the timing of the top line data from all three Phase 3 clinical trials, the timing of submission of an NDA to the FDA 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 planned 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; any delays or inability to obtain, regulatory approval of its product candidates; its ability to obtain adequate clinical supplies of the drug and device components of its product candidates; 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
; its ability to obtain and maintain regulatory approvals of its product candidates; the market potential for its product candidates; 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 three months ended
, 2012. 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.
SOURCE AcelRx Pharmaceuticals, Inc.