AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) were somewhat flat Wednesday, after the company received European Commission approval for DZUVEO.
The Redwood City, California-based AcelRx is a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings. The company 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 E.C. approval for an AcelRx developed product, with the first being ZALVISO, which is currently being marketed in Europe by Grünenthal.
DZUVEO, under development as DSUVIA in the U.S., 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.
Shares were unchanged mid-morning Wednesday to $3.85
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