Sufentanil Hybrid Gets Nod in EU for Moderate to Severe Pain

Megan Brooks


April 27, 2018

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has endorsed sufentanil (Dzuveo, FGK Representative Service GmbH) for the management of acute moderate to severe pain in adult patients.

Dzuveo is a hybrid medicine of Sufenta (Akorn), which has been approved in the European Union 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.

Hybrid applications include data from studies on the new product as well as for a reference product, according to the EMA.  

The active ingredient in Dzuveo, sufentanil, is an opioid that produces analgesia via activation of μ-opioid receptors primarily within the central nervous system.

Dzuveo will be available as 30-microgram sublingual tablets. The most common side effects are nausea, vomiting, and pyrexia.

Dzuveo should be administered only by healthcare professionals who are experienced in the management of opioid therapy.

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.

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