The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for recommending the granting of a marketing authorization to the medicinal product sufentanil (Dzuveo) for management of acute moderate to severe pain in adult patients. The applicant for this medicinal product is FGK Representative Service GmbH.
Dzuveo is a hybrid medicine of Sufenta which has been authorized in the EU since 1978. A hybrid medicine is a drug that is similar to an authorized medicine containing the same active substance but that differs in characteristics such as strength, indication, or pharmaceutical form.DZUVEO, known as DSUVIA™ (sufentanil sublingual tablet, 30 microgram) in the U.S., 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.
The drug will be available as 30-microgram sublingual tablets. Its active substance is sufentanil, an opioid which produces analgesia by activating µ-opioid receptors primarily within the central nervous system. Its most common side effects include vomiting, nausea, and pyrexia.
Dzuveo was developed by AcelRx Pharmaceuticals, a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings.
Hybrid applications include data from studies on the new product as well as for a reference product, according to the EMA.
Dzuveo should be administered only by healthcare professionals who are experienced in the management of opioid therapy.
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.
Detailed recommendations for the use of Dzuveo will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the European Commission grants marketing authorization.