AcelRx Pharmaceuticals, Inc. today announced positive results from a Phase 2 clinical trial of ARX-03, a proprietary sublingual dosage form combining an opioid, sufentanil, with a benzodiazepine, triazolam. ARX-03 is designed to address the current unmet need for a non-invasive product to provide mild sedation, anxiolysis and analgesia with rapid onset of action for the increasing number of painful and anxiety-producing office-based procedures. The objective of this randomized, double-blind, placebo-controlled study was assessment of safety, tolerability and efficacy of ARX-03 relative to placebo in patients undergoing an elective low-volume abdominal liposuction procedure.
In the study, 40 patients were randomized to receive either a single sublingual dose of ARX-03 (sufentanil 15 mcg/triazolam 200 mcg NanoTab(TM)) or placebo prior to the injection of a local anesthetic and the subsequent liposuction procedure. The primary endpoint was efficacy of ARX-03 compared to placebo in providing mild sedation during the procedure, as assessed using the validated, objective Richmond Agitation-Sedation Scale (RASS). The cumulative RASS score over the 4-hour study period was significantly better for active than for placebo (p <0.001) and a separation from placebo was seen as early as 30 minutes post-dosing>
A key secondary endpoint was the efficacy of ARX-03 in reducing anxiety compared to placebo. The cumulative anxiety score (patient-reported 11-point scale) over 4 hours was significantly lower for active than for placebo>
Lead investigator Dr. Neil Singla, commented, "The strong safety profile and high global satisfaction ratings speak to the advantages of this product. The blinded Physician Global Efficacy rating of 'Very Good' or 'Excellent' for 62% of the active patients versus 5% for the placebo patients demonstrates both the utility and efficacy of this product. I think this product has exceptional promise as a routine pre-procedure treatment appropriate for many different office-based procedures, especially since the discharge readiness was not different between active and placebo groups."
Pamela Palmer, MD, PhD, AcelRx Chief Medical Officer stated, "There is a growing need for a safe, non-invasive, rapid-acting medication explicitly developed for use in relieving patients' pain and anxiety during painful outpatient procedures, such as breast and prostate biopsies, performed in the clinician office setting. We are developing ARX-03 to meet this need, and with this first Phase 2 study we have laid the groundwork by demonstrating that ARX-03 can be dosed just prior to a procedure and produce safe, objectively measured mild sedation, along with anxiolysis and analgesia with rapid onset, that should translate into a meaningful improvement in both the patient and physician experience."
AcelRx Pharmaceuticals, Inc.