Ionsys gains EU marketing go-ahead

USA-based drug-delivery specialist Alza, an affiliate of Johnson & Johnson, says that the European Commission has granted marketing authorization across all 25 member states for the use of Ionsys (fentanyl hydrochloride Iontophoretic transdermal system), in the management of acute- to-moderate post-operative pain. The product is a needle-free, iontophoretic, patient-controlled analgesic delivery system, and is the first of its kind to gain regulatory authorization in the European Union.

The product will be marketed in Europe by a second J&J affiliate, Janssen-Cilag, while Alza will concentrate on the development of its manufacturing process and scale up for the product's launch, which is expected in 2007. Ionsys is also under review by the US Food and Drug Administration and, if approved, will be sold by J&J's Ortho-McNeil group direct to hospitals.