AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain.
Its two late-stage product candidates, ARX-04 and Zalviso®, were developed using the Company's non-invasive, sublingual formulation technology to deliver sufentanil, an opioid. The product candidates have completed clinical trials and have demonstrated potential for relief of moderate-to-severe acute pain in post-operative and other medically supervised settings.
In the United States, ARX-04 and Zalviso have completed pivotal Phase 3 placebo-controlled trials resulting in clinically significant acute pain relief (p value <0.001 for both ARX-04 and Zalviso as measured by Summed Pain Intensity Difference to Baseline in Phase 3 studies).
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. For more information on partnering opportunities, click here.
Zalviso is currently approved by the European Commission (EC) and has received the CE Mark approval (Conformite Europeene) for the Zalviso device, for the management of acute moderate-to-severe post-operative pain in adult patients in a hospital setting. Grünenthal Group, AcelRx's licensee in Europe and Australia, began its launch of Zalviso in April 2016 to hospitals in Germany. Based on their success with this initial launch program, Grünenthal initiated the sale of Zalviso in France, the United Kingdom, Italy, and Belgium and Netherlands in the second half of 2016. Additional European countries will be added to the Grünenthal launch program throughout the remainder of 2016 and into 2017.