BRIEF—FDA advisory panel backs approval Of Dsuvia

The Anesthetic and Analgesic Drug Products Advisory Committee of the US Food and Drug Administration voted 10-3 in favor of recommending the approval of AcelRx Pharmaceuticals’ Dsuvia (sufentanil sublingual table) 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 30mcg sufentanil tablet in a pre-filled applicator for sublingual administration by a healthcare professional.

"We are pleased with the Advisory Committee's recommendation to approve Dsuvia as a treatment in medically supervised settings for adults experiencing moderate-to-severe acute pain," said Dr Pamela Palmer, co-founder and chief medical officer of AcelRx.

"We look forward to continued collaboration with the FDA on the application as we believe Dsuvia represents an important non-invasive acute pain management option with potential to significantly improve the current standard of care."

Under the brand name Dzuveo the European Commission approved the drug in June this year.