Each year in the United States, more than 100 million procedures that are potentially anxiety-inducing and painful take place in a physician’s office. These procedures include interventional radiology procedures, diagnostic procedures such as breast and prostate biopsies, cosmetic procedures such as liposuction and dermal abrasions, and therapeutic procedures such as vasectomies and endometrial ablation procedures. IV sedative medications are typically not offered to these patients because of the high cost associated with the specialized personnel and monitoring equipment necessary for IV sedation. Despite the high potential for pain and anxiety during these procedures, most patients currently undergo these procedures with only a local anesthetic.

ARX-03 is a NanoTab product candidate designed to be administered sublingually to provide mild sedation, anxiety reduction and pain relief prior to a painful procedure in a physician’s office. ARX-03 is a physician- or nurse-administered combination of sufentanil and triazolam designed to have rapid onset of effect. ARX-03 may eliminate the need for specialized personnel and require only minimal monitoring equipment, which we believe would allow it to be used cost-effectively in the physician’s office.

Key potential benefits of ARX-03 include:

• A non-invasive approach to mild sedation, anxiety reduction and pain relief
• Sublingual product that is easy to administer
• Rapid onset of effect. (Onset of sedation and anxiety reduction in 15-30 minutes was observed in our Phase 2 trial)
• Provides JCAHO Level 1 (minimal sedation) instead of Level 2 or Level 3 (moderate to deep) sedation; therefore, no need for specialized personnel or monitoring equipment
• Physician- or nurse-administered, and
• Patient discharge time is unaffected.

ARX-03 Development Status

AcelRx has reported results of a Phase 1 proof-of-concept study evaluating both sedation and pharmacokinetic properties of ARX-03. More recently, AcelRx reported positive results from a Phase 2 trial assessing the safety, tolerability, and efficacy of ARX-03 in patients undergoing elective low-volume liposuction procedure. Also, AcelRx completed an end-of-Phase 2 meeting with FDA.

ARX-03 Publications and Press Releases

Positive Results from a Phase 2 Study

Press release

Positive Results from a Clinical Trial of Sublingual Sufentanil/Triazolam NanoTab™

Press release