ARX-01 Sufentanil NanoTab PCA System

Acute pain management in the hospital, in particular post-operative analgesia, remains a significant challenge for healthcare providers. Annually, approximately 8 million patients in the U.S. receive intravenous (IV) patient-controlled analgesia (PCA), typically utilizing morphine, for inpatient post-operative pain, with a similar number in the E.U. Despite its widespread use, the IV PCA architecture has several limitations. The IV line tethering the patient to the PCA pump discourages mobility, which is a critical factor in preventing post-operative complications and advancing recovery. Furthermore, the invasive nature of the IV delivery mode poses infection risk as well as predisposition to analgesic gaps due to infiltrated and dislodged IV catheters. Additionally, the complexity and programmability of IV PCA pumps introduce opportunities for medication errors, which in some instances may be fatal. The ARX-01 Sufentanil NanoTab PCA System avoids many of the limitations of IV PCA approaches by providing a non-invasive, pre-programmed, handheld PCA solution.

The ARX-01 Sufentanil NanoTab PCA System is a novel drug/device combination product candidate designed for use in hospital settings to provide non-invasive patient-controlled analgesia and maximize patient satisfaction with post-operative pain management. The handheld component of ARX-01 allows for convenient patient self-administration of Sufentanil NanoTabs sublingually for oral transmucosal absorption. Sufentanil is a high therapeutic index opioid approved for intravenous and epidural administration. Although the analgesic efficacy of sufentanil has been well established, its use has been limited due to its short IV plasma half-time. In the NanoTab oral transmucosal dosage form, sufentanil demonstrates a therapeutically appropriate pharmacokinetic profile for post-operative PCA usage. 

AcelRx has reported positive Phase 2 results from a multicenter, double-blind, randomized, placebo-controlled, dose-finding study that evaluated the safety and efficacy of Sufentanil NanoTabs in patients undergoing elective unilateral knee replacement surgery. View press release.

AcelRx has also reported positive Phase 2 results from a multicenter, double-blind, randomized, placebo-controlled study that evaluated the safety and efficacy of Sufentanil NanoTabs in patients undergoing major abdominal surgery. View press release.

Additionally, the ARX-01 Sufentanil NanoTab PCA System performed perfectly in an open-label Phase 2 study assessing the functionality of the handheld component. View press release.

Scientific abstracts and presentations related to the ARX-01 Sufentanil NanoTab PCA System:

  • Single and Repeat-Dose Pharmacokinetics of Sublingual Sufentanil NanoTab in Healthy Volunteers. Pamela P. Palmer, M.D., Ph.D., Larry G. Hamel, Roman J. Skowronski, M.D., Ph.D. 2009 American Society of Anesthesiologists Annual Meeting. View abstract.

  • A Phase 2 Open-Label Functionality, Safety, and Efficacy Study of the Sufentanil NanoTab™ PCA System in Patients Following Elective Unilateral Knee Replacement Surgery. David Griffin, MD, Vero Beach, FL, Roman Skowronski, MD, PhD, Redwood City, CA, Pamela Palmer, MD, PhD, Redwood City, CA. 2010 American Society of Regional Anesthesia Spring Meeting. View abstract.

  • A Phase 2 Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of Sublingual Sufentanil NanoTab™ in Patients Following Elective Unilateral Knee Replacement Surgery. Harold Minkowitz, MD, Houston, TX Roman Skowronski, MD, PhD, Redwood City, CA; Pamela Palmer, MD, PhD, Redwood City, CA. 2010 American Society of Regional Anesthesia Spring Meeting. View abstract.

  • A Phase 2 Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of Sublingual Sufentanil NanoTab™ in Patients Following Major Abdominal Surgery. Neil Singla, MD, Pasadena, CA, Roman Skowronski, MD, PhD, Redwood City, CA, Pamela Palmer, MD, PhD, Redwood City, CA. View abstract.

Click play below to view the video.