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AcelRx Pharmaceuticals receives European regulatory approval for its opioid pain killer DZUVEO

DZUVEO is still under development in the US where it is known as DSUVIA
The European Commission has already approved AcelRx's other painkiller, Zalviso

AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) won plaudits today after the European Commission approved its opioid painkiller DZUVEO for managing acute to severe pain in adults.

DZUVEO (a 30 microgram sufentanil sublingual tablet), which is still under development in the US, where it is known as DSUVIA, is meant to cut acute moderate to severe pain following various surgeries.

“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,” said Vince Angotti, chief executive of AcelRx.

READ: AcelRx Pharmaceuticals gets go-ahead from the FDA to resubmit a new drug application for DSUVIA

The European Commission’s approval of DZUVEO marks AcelRx’s second approval by European regulators. Its milder painkiller Zalviso is currently being marketed in Europe by Grunenthal.

Here in the US, the US Food and Drug Administration has assigned AcelRx a prescription drug user fee act date of November 3, 2018, for a decision on its resubmitted new drug application for DSUVIA.

In early afternoon trade, AcelRX shares remained unchanged at US$3.85.

Contact Ellen Kelleher: [email protected]

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