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AcelRx Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain. The Company`s product candidates, DSUVIA™ (known as ARX-04 outside of the United States) and ZALVISO®, are designed to deliver sufentanil, a strong opioid analgesic, via a non-invasive, sublingual formulation in medical supervised settings. DSUVIA is designed to deliver sublingual tablets containing 30 mcg sufentanil via a disposable, pre-filled, single-dose applicator. The Phase 3 clinical program has completed and assessed the investigational product in the treatment of moderate-to-severe acute pain in patients who had undergone surgery or who presented to an emergency room with trauma or injury. In clinical studies, DSUVIA demonstrated reductions in pain intensity as early as 15-to-30 minutes after the start of dosing and the most common adverse events included nausea, headache, dizziness, and vomiting. A New Drug Application (NDA) was filed with the FDA in December 2016. ZALVISO is designed to deliver sublingual tablets containing 15 mcg sufentanil via a novel hand-held, pre-programmed, patient-controlled analgesia system. Three Phase 3 clinical trials have been completed in patients who had undergone major abdominal or orthopedic surgeries. A fourth study (IAP312) is underway to further evaluate the overall performance of the ZALVISO System in post-surgical patients. ZALVISO is currently approved by the European Commission for the management of acute moderate-to-severe post-operative pain in adult patients in a hospital setting, and is marketed by Grünenthal Group, AcelRx`s licensee in Europe and Australia. In the United States and other geographies, ZALVISO remains an investigational product.
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