AcelRx Pharmaceuticals, Inc. (ACRX), Monday said the Zalviso New Drug Application or NDA was accepted for filing by the FDA on November 26. The NDA, which was submitted on September 27 sought approval for the marketing and sale of an investigational pre-programmed, non-invasive, handheld system, Zalviso for the management of moderate-to-severe acute pain in adult patients in the hospital setting.
The submission was based on data from a Phase 3 registration program, that included two clinical trials, one conducted in patients following major abdominal surgery, the other in patients following major joint replacement surgery. Also, 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. The primary efficacy endpoints for these studies were achieved.
For comments and feedback: editorial@rttnews.com