AcelRx commences dosing in second ARX-01 Phase 3 clinical trial for acute post-operative pain

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, today reported dosing of the first patient in the second of three planned Phase 3 studies that will form the basis of a planned New Drug Application (NDA) for the Sufentanil NanoTab® PCA System, ARX-01.  Utilizing a multicenter, randomized, open-label, parallel-group design, the study will compare the efficacy and safety of the Sufentanil NanoTab PCA System to the standard of care, IV PCA with morphine, in the treatment of acute post-operative pain immediately after major abdominal or orthopedic surgery.  The primary objective of the study is to demonstrate non-inferiority of ARX-01 to IV PCA with morphine as determined by patient global satisfaction with the method of pain relief.  Approximately 400 adult patients, randomized 1:1 to treatment with ARX-01 or IV PCA with morphine, will be treated for post-operative pain for a minimum of 48 hours after randomization.  The study will be conducted at approximately 32 academic and community hospitals in the United States with top-line data expected in second half of 2012.

In March 2012, AcelRx initiated its first Phase 3 clinical study for ARX-01, a randomized, double-blind, placebo-controlled efficacy and safety study comparing ARX-01 to placebo for post-operative pain control following major open abdominal surgery.  Data from this study is expected in second half of 2012.  A third Phase 3 clinical study for ARX-01, expected to start in the third quarter of 2012, will be a randomized, double-blind, placebo-controlled efficacy and safety study comparing ARX-01 to placebo in treating post-operative pain following major joint replacement surgery.

"We are extremely pleased to have our second ARX-01 Phase 3 clinical trial underway.  This study is expected to meet several objectives.  Firstly, in addition to the two placebo-controlled studies, data from this active-comparator study will complete our ARX-01 safety database enabling review for marketing approval by regulatory agencies in the US and Europe.  Secondly, positive results from this study demonstrating that pre-programmed, non-invasive delivery of Sufentanil NanoTabs provide non-inferior pain relief compared to IV PCA with morphine could support commercial adoption.  Finally, secondary endpoint data from this study including comparison of average dosing intervals, sedation scores, system-related events and ease of care questionnaires, could support the pharmacoeconomic advantage of ARX-01, which we believe will help support adoption of the product in the US, and enable pricing of the product in Europe," said Richard King, AcelRx's Chief Executive Officer.  Mr. King added, "This year is an exciting time for AcelRx, with the delivery of top-line data from all three ARX-01 Phase 3 clinical trials expected by late 2012 or early 2013."