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, Zalviso™, is designed to address 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 for a number of reasons, including 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. Zalviso is designed to address these problems by utilizing:

  • sufentanil, a high therapeutic index opioid;
  • our sublingual dosage form; and
  • our novel, factory-programmed handheld PCA device being evaluated for simplifying patient controlled delivery of sufentanil tablets in the hospital setting and reduced programming errors by the end user.

Our Zalviso Phase 3 clinical program consisted of three trials; two placebo-controlled efficacy and safety trials and one open-label active comparator trial, in which Zalviso was compared to IV PCA morphine. AcelRx has announced positive results from each of the three Phase 3 clinical trials for Zalviso and has submitted an NDA to the FDA seeking its approval. We have successfully completed Phase 2 clinical development for three 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. The third additional product candidate, ARX-04, is designed to provide a non-invasive, fast-onset treatment of moderate-to-severe acute pain in patients with trauma or injury and has been funded by the Department of Defense. All of our product candidates utilize our sufentanil tablet sublingual dosage form which we believe may help address 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.

AcelRX

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