AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending approval of  Dzuveo (known as Dzuveo in the US) for the management of acute moderate to severe pain in adults in medically monitored settings.

"The CHMP positive opinion recognizes the compelling efficacy and safety profile of Dzuveo and is a significant step forward in bringing a novel, non-invasive medicine that could potentially transform the management of moderate to severe acute pain in medically monitored settings for healthcare systems, providers and patients in Europe," said Vince Angotti, chief executive officer of AcelRx. "We believe the market opportunity is significant, with annually over 51 million patients visiting emergency departments and 16 million patients post-surgery experiencing moderate to severe acute pain in just the five largest EU countries."

The CHMP positive opinion is now referred to the European Commission, which grants a centralized marketing authorization with unified labeling that is valid in the 28 countries of the European Union (EU), as well as European Economic Area members, Iceland, Liechtenstein and Norway. AcelRx anticipates that the European Commission decision will be adopted within approximately two to three months.

Based on the clear path provided by the FDA Type A meeting and subsequent successful completion of the Human Factors study, the Company is planning to resubmit the New Drug Application for Dzuveo (known as Dzuveo in Europe) with the US Food and Drug Administration (FDA) in the second quarter of 2018.
Dzuveo, known as Dzuveo (sufentanil sublingual tablet, 30 microgram) in the US, is designed to reduce acute moderate-to-severe pain and address dosing errors associated with IV administration via its non-invasive single-dose applicator (SDA) in medically monitored settings. Sufentanil is an opioid analgesic currently marketed for intravenous (IV) and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually potentially avoids the high peak plasma levels and short duration of action observed with IV administration. In the US, the company is planning to submit a New Drug Application (NDA) for Dzuveo with the FDA in Q2 2018.

AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.