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AcelRx Pharmaceuticals inc. recently announced that the U.S. Food and Drug Administration's (FDA) Advisory Committee on Anesthetic and Analgesic Drug Products (AADPAC) has met to vote on the company's painkiller, Dzuveo, which voted 10 to 3 against to approve Dsuvia for the management of acute moderate to severe pain in adults in a medical monitoring environment. Developed to meet the challenges of existing treatment options, Dsuvia is tongue-in-cheek, easy to deliver, and can quickly relieve pain in up to 15 minutes.
Dsuvia is a sub-tongue tablet containing 30 micrograms of the active drug ingredient sufentanil, an opioid that reduces the pain response by acting on μ opioids in the central nervous system.
Dsuvia, as a non-invasive painkiller, has the potential to significantly improve current standards of care, allowing medical personnel to treat patients with moderate to severe acute pain in emergency rooms, inpatient buildings, operational care facilities, or battlefield settings.
in clinical studies, Dsuvia showed good tolerance and was effective in treating moderate-severe acute pain as a non-invasive painkiller in patients of all ages and with different body mass index (BMI). Dsuvia's benefits of rapid pain relief, non-invasive sub-tongue medication, and fewer side effects make it a great treatment option for analgesic treatment in emergency rooms and outdoor environments.
Dsuvia is another dosage form of the analgesic Sufenta, which was introduced in the European Union in 1978 and contains the same active drug ingredient, but is administered in different ways, and Sufenta produces an anesthetic analgesic effects through intravenous administration.
the end of June this year, Dsuvia was approved by the European Commission to list under the brand name Dzuveo, and the drug represents AcelRx's second product approved in Europe, the first of which is Zalviso, a drug-device system A dedicated, pre-programmed, non-invasive patient-controlled analgesic device delivers 15 micrograms of scifentanine tablets for acute moderate to severe pain management in adult patients, and the product is currently being sold in Europe by the Grunthal Group. (Bio Valley)
