CHMP recommends Ionsys transdermal system + fentanyl for acute moderate-to-severe, post-operative pain in adult patients- The Medicines Company
The Medicines Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending marketing authorization for Ionsys (40 micrograms per dose transdermal system), with active ingredient fentanyl, for the short-term management of acute moderate-to-severe, post-operative pain in adult patients. Ionsys will be the only needle-free, patient-controlled, pre-programmed fentanyl delivery system for use in patients requiring opioid analgesia in EU hospital settings.
Comment: Inosys was developed originally by Johnson and Johnson (J&J) but although approved in the US and EU in 2006 it was never launched in the US. An EMEA advisory committee recommended suspension of the drug due to a faulty delivery system after its launch in Europe.The Medicines Company gained access to the product by its acquisition of Incline Therapeutics Inc. which had acquired the drug from J&J in 2010.
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