AcelRx says FDA advisory committee recommeds approval of Dsuvia
AcelRx Pharmaceuticals announced that the Anesthetic and Analgesic Drug Products Advisory Committee of the FDA voted 10-3 in favor of recommending the approval of Dsuvia for the management of moderate-to-severe acute pain in medically supervised settings for adult patients. Developed to address challenges with existing treatment options and to provide an easy-to-administer dosage form for rapid relief as early as 15 minutes, Dsuvia is a 30 mcg sufentanil tablet in a pre-filled applicator for sublingual administration by a healthcare professional. While the FDA is not bound by the committee's recommendation, it does take its advice into consideration. The Prescription Drug User Fee Act, or PDUFA, date for Dsuvia is November 3.