- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval for The Medicines Company's (MDCO -0.7%) IONSYS (fentanyl iontophoretic transdermal system) for the short-term management of adult patients with acute moderate-to-severe post-operative pain.
- If approved, IONSYS will be the only needle-free, patient-controlled, pre-programmed fentanyl delivery system for patients requiring opioid analgesia in EU hospital settings.
- A final decision by the European Commission usually takes ~60 days.
- The FDA cleared IONSYS in May.