FDA Advisory Committee recommends approval of Dsuvia to treat moderate-to-severe acute pain.- AcelRx Pharmaceuticals

AcelRx Pharmaceuticals, Inc. 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, Dsuviais a 30 mcg sufentanil tablet in a pre-filled applicator for sublingual administration by a healthcare professional.

The company presented Dsuvia efficacy and safety data from two randomized, placebo-controlled studies with a total of 261 patients and two open-label, single-arm studies with a total of 216 patients. In these clinical trials, Dsuvia was shown to be well-tolerated and demonstrated efficacy across a range of patient ages and BMIs as a non-invasive analgesic for the management of moderate-to-severe acute pain.

Dsuvia has a PDUFA date of 3 November 2018 and has been approved in the EU in June 2018.