Zalviso™, our lead program, has completed Phase 3 development and an NDA has been submitted to the FDA seeking its approval. The product was developed to address some of the challenges associated with intravenous patient-controlled analgesia (IV PCA), which is the standard means of treating moderate-to-severe acute pain in the hospital setting. Although widely used, IV PCA has been shown to cause harm to patients following surgery and treatment of other moderate-to-severe painful conditions due to 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:
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. Each of the three Phase 3 trials achieved its primary endpoint, and we believe the trial data supports the submission of a New Drug Application, or NDA, which has been submitted to the FDA seeking its approval.
Zalviso has the potential to provide effective acute pain control, while minimizing some of the limitations associated with IV PCA.
ARX-02 is a potential new treatment option for patients who suffer from breakthrough pain (BTP) due to cancer that has completed Phase 2 development. The ARX-02 system consists of a device containing 30 single dose applicators, each of which contains a single sufentanil NanoTab that a patient can self-administer under their tongue for rapid sublingual 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 breakthrough pain relieving medication, with misuse and abuse-deterrent packaging.
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 has completed Phase 2 development. ARX-03 is a combination of sufentanil and triazolam in the NanoTab technology platform 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 reduce the need for specialized personnel and monitoring equipment, potentially allowing it to be used cost-effectively in the physician’s office.
ARX-04 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. ARX-04 has successfully complete Phase 2 clinical trials wherein we have identified the dose (30 mcg of sufentanil per tablet ) to further evaluate in Phase 3. 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 in preparation for Phase 3 development.