AcelRx Announces Initiation of Phase 3 Clinical Program for ARX-01, the Sufentanil NanoTab® PCA System for the Treatment of Post-Operative Pain

AcelRx Pharmaceuticals, Inc.

reported dosing of the first patient in a Phase 3 study for ARX-01, the Sufentanil NanoTab PCA System, its novel sublingual patient-controlled analgesia system. This first ARX-01 Phase 3 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 3 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.