AcelRx Pharma Issues NDA for Zalviso, Submission Required Payment of $1.95M to FDA

AcelRx Pharmaceuticals, Inc.

, a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today 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 major abdominal surgery, the other in patients following major joint replacement surgery.  Additionally, a Phase 3 open-label active-comparator trial was conducted in patients following either major abdominal or orthopedic surgery, comparing Zalviso to the current standard of care, intravenous patient-controlled analgesia (IV PCA) with morphine.  Zalviso successfully achieved the primary efficacy endpoints for