AcelRx Pharmaceuticals announced the Anesthetic and Analgesic Drug Products Advisory Committee of the U.S. Food and Drug Administration (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. Dsuvia is a 30 mcg 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."
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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.
The Anesthetic and Analgesic Drug Products Advisory Committee is convened upon the request of the FDA to review and evaluate safety and efficacy data of marketed and investigational human drug products for use in anesthesiology and surgery, and makes appropriate recommendations to the Commissioner of Food and Drugs. While the FDA is not bound by the committee's recommendation, it does take its advice into consideration. The Prescription Drug User Fee Act (PDUFA) date for DSUVIA is November 3, 2018.
"The availability of a single-dose, non-invasive opioid, like Dsuvia, could significantly improve my ability to effectively, efficiently and safely alleviate acute pain experienced by my patients," said David Leiman, M.D., Clinical Assistant Professor of Surgery, University of Texas at Houston, and Director, HD Research Corp. "It is my hope that the FDA consider the recommendation of the Advisory Committee and the current need for additional non-invasive opioid analgesic options on behalf of patients and healthcare providers in medically supervised settings."