A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-03 Sublingual Sufentanil/Triazolam 15 mcg/200 mcg NanoTab in Patients Undergoing an Elective Abdominal Liposuction Procedure.

 

Many patients are anxious and uncomfortable during office-based aesthetic, diagnostic and therapeutic procedures, which can negatively impact both the patient and the surgeon. ARX-03 is a new sublingual product combining sufentanil with triazolam and is in development to provide mild sedation, anxiolysis and analgesia with rapid onset of action for painful office-based procedures.

Since ARX-03 is designed for Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) Level 1 sedation (minimal sedation), administration of ARX-03 will not require the level of staff monitoring mandated for intravenous sedation. In this randomized Phase 2 study, 40 patients undergoing low-volume liposuction received either a single sublingual dose of ARX-03 (sufentanil 15 mcg/triazolam 200 mcg NanoTab) or placebo prior to injection of a local anesthetic.

Download PDF