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>