European Commission approval for Dzuveo

The European Commission (EC) has approved Dzuveo (sufentanil sublingual tablet; under development in the USA as Dsuvia) for the management of acute moderate to severe pain in adults in medically monitored settings, said the drug’s developer, AcelRx Pharmaceuticals (Nasdaq: ACRX).

The approval comes following the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommendation in late April, and the news saw the California-based company’s shares gain2.6% to $3.05 in pre-market trading today.

"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 AcelRx, adding: "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."