AcelRx Pharmaceuticals, a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings, announced that the European Commission (EC) has approved DZUVEO (under development in the U.S. as DSUVIA™) for the management of acute moderate to severe pain in adults in medically monitored settings.
DZUVEO represents the second EC approval for an AcelRx developed product, with the first being ZALVISO, which is currently being marketed in Europe by Grünenthal.
DZUVEO (sufentanil sublingual tablet, 30 microgram) is designed to reduce acute moderate-to-severe pain in medically monitored settings and address dosing errors associated with intravenous (IV) administration via its non-invasive single-dose applicator (SDA). Sufentanil is an opioid analgesic currently marketed for 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 while still providing rapid pain relief. The safety and clinical utility of DZUVEO has been established in patients following multiple types of surgery, as well as in patients presenting to the emergency room with moderate to severe pain due to trauma, injury or illness.
AcelRx previously announced the acceptance of the resubmitted New Drug Application for DSUVIA (approved in Europe as DZUVEO) by the U.S. Food and Drug Administration, for which the FDA has assigned a PDUFA (Prescription Drug User Fee Act).
AcelRx Pharmaceuticals (Redwood City, California, USA) is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx’s proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles.