FDA to review AcelRx's Zalviso for pain

FDA accepted for review an NDA from AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) for Zalviso sufentanil sublingual microtablet system to manage moderate to severe acute pain in a hospital setting. The company submitted the application in September. A standard 10-month review would place the PDUFA date in July; the company is not yet disclosing the specific PDUFA date. The NDA was submitted under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products. Zalviso (formerly Sufentanil NanoTab PCA System) is a pre-programmed, handheld device that delivers a sublingual formulation of sufentanil, a synthetic opioid analgesic. ...