Posted by Michael Wonder on 03 Nov 2018
AcelRx announces FDA approval of Dsuvia
2 November 2018 - First and only sufentanil sublingual tablet approved for acute pain in health care settings.
AcelRx Pharmaceuticals announced today the approval of Dsuvia by the U.S. FDA. Dsuvia is indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments.
The efficacy and safety of DSUVIA were evaluated in one randomised, double-blind, placebo-controlled trial which enrolled 161 patients (age 18 to 69 years) with acute postoperative pain (pain intensity of ≥ 4 on a 0-10 numeric rating scale) after abdominal surgery (studied up to 48 hours). Patients were dosed with Dsuvia 30 mcg or placebo as needed with a minimum of 60 minutes between doses. Morphine sulphate 1 mg IV was available as rescue medication.
