Overview
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain. Our lead product candidate, the ARX-01 Sufentanil NanoTab® PCA System, is designed to solve the problems associated with post-operative intravenous patient-controlled analgesia, or 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, our proprietary, non-invasive sublingual dosage form; and
- our novel handheld PCA device that enables simple patient-controlled delivery of NanoTabs in the hospital setting and eliminates the risk of programming errors.
We are preparing to initiate Phase 3 clinical trials for ARX-01. We have completed Phase 2 clinical development for two additional product candidates, the ARX-02 Sufentanil NanoTab Breakthrough Pain Management System for the treatment of cancer breakthrough pain, and the ARX-03 Sufentanil/Triazolam NanoTab which is designed to provide mild sedation, anxiety reduction and pain relief for patients undergoing painful procedures in a physician’s office. An additional product candidate, ARX-04, designed to provide a non-invasive, fast-onset treatment of moderate-to-severe acute pain in patients with trauma or injury, is entering Phase 2 under a grant funded by the Department of Defense. All of our product candidates utilize sufentanil in our proprietary, non-invasive NanoTab sublingual dosage form which we believe overcomes the limitations of current treatment options for both acute and breakthrough pain.
In the United States, AcelRx is planning to develop and commercialize these product candidates, either through its own efforts or in conjunction with partners. Outside of the United States, AcelRx anticipates commercializing these products on a worldwide basis through select regional partnerships.