AcelRx Announces Date of FDA Advisory Committee Meeting for Dsuvia

AcelRx Pharmaceuticals announced the Anesthetic and Analgesic Drug Products Advisory Committee of the U.S. Food and Drug Administration (FDA) has planned an Advisory Committee meeting to review the company's New Drug Application (NDA) for Dsuvia for the management of moderate-to-severe acute pain in medically supervised settings in adult patients.

"We have been actively preparing for this meeting since the beginning of the year, and we're looking forward to sharing our DSUVIA data with the Advisory Committee," said Dr. Pamela Palmer, Co-Founder and Chief Medical Officer at AcelRx. "If approved, we believe that Dsuvia will provide a novel non-invasive treatment option for moderate-to-severe acute pain in medically supervised settings."

The FDA accepted AcelRx's NDA in May 2018. The target action date under the Prescription Drug User Fee Act (PDUFA) is November 3, 2018.

Dsuvia (sufentanil sublingual tablet, 30 microgram), known as Dzuveo outside the United States, has a proposed indication for the management of moderate-to-severe acute pain in medically supervised settings, in adult patients and was designed to eliminate dosing errors associated with IV administration via its non-invasive single-dose applicator (SDA) administered by healthcare professionals. Sufentanil is an opioid analgesic currently marketed for intravenous (IV) and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Medicines Agency (EMA) approved Dzuveo for marketing in Europe in June 2018.

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