AcelRx Pharmaceuticals, Inc. of Redwood, Calif., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, will announce the results of its multicenter, open-label Phase 3 clinical study of ARX-04, known as SAP303. The study was conducted in patients 40 years and older who have moderate-to-severe acute pain following a surgical procedure. Patients were administered one dose of ARX-04 (sufentanil sublingual tablet, 30 mcg) every 60 minutes, as needed for pain management, for up to 12 hours.
ARX-04 is a non-invasive investigational product candidate consisting of a 30 mcg sufentanil tablet delivered sublingually in a controlled setting by healthcare professionals using a disposable, pre-filled, single-dose applicator (SDA). Sufentanil is a synthetic opioid analgesic with a high therapeutic index and no known active metabolites.
AcelRx is developing ARX-04 for the management of moderate-to-severe acute pain in a variety of medically supervised settings, including the emergency room, outpatient or ambulatory surgery, non-surgical patients experiencing moderate-to-severe acute pain in the hospital, and post-operative patients following short-stay surgery, who do not require more long-term patient-controlled analgesia (PCA).
The ARX-04 Phase 3 clinical program is comprised of three studies in patients with moderate-to-severe acute pain: SAP301, a double-blind, placebo-controlled trial in ambulatory abdominal surgery patients; SAP302, an open-label trial in adult emergency room patients; and SAP303, an open-label trial in post-operative patients. Results of SAP301, which were presented in 2015 at the American Society of Anesthesiologists annual meeting, and results of SAP302, which were presented at the 2016 Military Health System Research Symposium, may be viewed on the AcelRx website.
ARX-04 is funded in part by the Clinical and Rehabilitative Medicine Research Program (CRMRP) of the U.S. Army Medical Research and Materiel Command (USAMRMC) under contract No. W81XWH-15-C-0046. – PRNewswire