EUROPEAN AUTHORITIES RECOMMEND APPROVAL FOR IONSYS
The European Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has adopted a positive opinion recommending marketing authorization for IONSYS(TM) (Fentanyl hydrochloride (HCl) Iontophoretic Transdermal System (ITS) 40 micrograms per dose) in the 25 member states of the European Union. According to the CHMP, the benefits with IONSYS(TM) are its ability to provide effective analgesia by means of a 24-hour pre-programmed iontophoretic transdermal system allowing non-invasive, patient-controlled delivery of fentanyl in acute post-operative pain of moderate to severe intensity for hospital use only. The European Commission generally follows the CHMP opinion and grants a final Marketing Authorization within a few months following a positive recommendation.
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