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AcelRx Pharmaceuticals Inc Submits New Drug Application To FDA For Zalviso

Monday, 30 Sep 2013 07:30am EDT 

AcelRx Pharmaceuticals, Inc announced that it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Zalviso (sufentanil sublingual microtablet system). Zalviso is a patient-activated, non-invasive analgesic system, which delivers 15 mcg sufentanil per dose as needed for pain control, subject to a 20 minute lockout period between doses. The proposed indication for Zalviso is the management of moderate-to-severe acute pain in adult patients in the hospital setting. The NDA submission is based primarily on data from a Phase 3 registration program that included two double-blind randomized placebo-controlled clinical trials, one conducted in patients following abdominal surgery, the other in patients following joint replacement surgery. 

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