Phase III trial begins of ARX-01 System (AcelRx Pharmaceuticals) for treatment of Post-Operative Pain

Dosing has begun in a Phase III study for ARX-01, the Sufentanil NanoTab PCA System from AcelRx Pharmaceuticals. 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. This first ARX-01 Phase III study is a randomized, double-blind, placebo-controlled efficacy and safety trial in adults following open abdominal surgery. Approximately 150 adults, randomized 2:1 to active or placebo groups, will be treated for post-operative pain for a minimum of 48 hours and, as needed, up to 72 hours after randomization. The study will be conducted at 12 academic and community hospitals in the United States. The remainder of the planned Phase III clinical program for ARX-01 includes a second randomized, double-blind, placebo-controlled efficacy and safety study comparing Sufentanil NanoTabs to placebo for post-operative pain control following major joint replacement surgery, and an open-label active-comparator study comparing ARX-01 to the current standard of care, intravenous patient-controlled analgesia, or IV PCA, with morphine. Top-line data from all three Phase III clinical trials is expected by late 2012 or early 2013.