AcelRx' Dzuveo has won approval in the European Union for the management of acute moderate to severe pain in medically monitored settings.
Dzuveo is a sublingual tablet formulation of the opioid analgesic sufentanil, designed to address dosing errors associated with intravenous (IV) administration of the drug via its non-invasive single-dose applicator.
"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 of the firm.
"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."
The drug is also currently under review in the US, where it is being developed under the brand name
AcelRx previously announced the acceptance of the resubmitted New Drug Application for Dsuvia.
Dzuveo is the second product developed by AcelRx to win approval in the European Union, following in the footsteps of Zalviso, which is currently being marketed in Europe by Grünenthal.