CHMP recommends approval of Dzuveo for acute moderate to severe pain.- AcelRX Pharma.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Dzuveo (sufentanil nanotab drug delivery) from AcelRX Pharma, intended for the treatment of pain. Dzuveo will be available as 30-microgramsublingual tablets. The active substance of Dzuveo is sufentanil, an opioid (ATC code: N01AH03) which produces analgesia by activating ?-opioid receptors primarily within the central nervous system.
The benefits with Dzuveo are its ability to reduce pain. The most common side effects are nausea, vomiting and pyrexia. Dzuveo is a hybrid medicine of Sufenta which has been authorised in the EU since 1978. Dzuveo contains the same active substance as Sufenta, but is given in a different way. The full indication is: "Dzuveo is indicated for the management of acute moderate to severe pain in adult patients".
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins