AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx or the Company), a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings, today 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.
“The EC approval is an important milestone for AcelRx, and an exciting new opportunity for healthcare providers for managing acute moderate to severe pain in medically monitored settings. The current standard of care in these settings is primarily intravenous opioids,” said Vince Angotti, Chief Executive Officer of AcelRx. “DZUVEO is a novel, non-invasive, sublingual tablet that we expect will challenge the current standard of care and provide a new option to healthcare practitioners that does not require the time, expense and effort to start an intravenous line.”
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.
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) date of November 3, 2018.
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