ARX-01 Sufentanil NanoTab® PCA System

The ARX-01 Sufentanil NanoTab PCA System, our lead program, was developed to solve the problems associated with post-operative intravenous patient-controlled analgesia (IV PCA). Although widely used, IV PCA has been shown to cause harm to patients following surgery because of the side effects of morphine, the invasive IV route of delivery and the inherent potential for programming and delivery errors associated with the complexity of infusion pumps. ARX-01 is designed to address these problems by utilizing:

• Sufentanil, a high therapeutic index opioid
• NanoTabs, a proprietary, non-invasive sublingual dosage form, and
• A novel hand-held PCA system that enables simple patient-controlled delivery of NanoTabs in the hospital setting that eliminates the risk of programming errors

ARX-01 has the potential to provide highly effective post-operative pain control, while minimizing some of the limitations, safety problems and side effects associated with IV PCA.

ARX-02 Sufentanil NanoTab® Breakthrough Pain (BTP) Management System

ARX-02 is a potential new treatment option for patients who suffer from breakthrough pain (BTP). The ARX-02 system consists of a magazine containing 30 single dose applicators, each of which contains a single sufentanil NanoTab that a patient can self-administer under their tongue for rapid transmucosal absorption. ARX-02 is designed to avoid many of the limitations of currently available cancer BTP medications by combining the rapid onset and appropriate offset of sufentanil with abuse-deterrent packaging. While there are several fentanyl-based BTP products both on the market and in development, ARX-02 offers the potential of both rapid onset of analgesia and a half-life that minimizes over medication once a BTP episode has resolved. Additionally, we have developed novel packaging intended to provide dose-tracking capability to assist in managing patients opioid use and deterring abuse.

ARX-03 Sufentanil/Triazolam NanoTab®

ARX-03 is a sublingual product candidate designed to provide non-invasive mild sedation, anxiety reduction and pain relief in patients prior to a painful procedure in a physician’s office. ARX-03 is a combination of sufentanil and triazolam in the NanoTab technology that can be easily administered sublingually by a healthcare professional, has been designed to provide rapid onset-of-effect without impacting recovery or discharge. ARX-03 may eliminate the need for specialized personnel and may require only minimal monitoring equipment, allowing it to be used cost-effectively in the physician’s office.

ARX-04 Sufentanil Acute Pain NanoTab®

ARX-04 is a sublingual sufentanil product candidate designed to provide a non-invasive, fast-onset treatment of patients with moderate-to-severe acute pain, both on the battlefield and in civilian settings of trauma or injury. AcelRx received a grant from the US Army Medical Research and Materiel Command (USAMRMC) to conduct a Phase 2 dose finding-study in moderate-to-severe acute pain, and to prepare to enter Phase 3 development.