Misodel (Ferring) approved in EU for Labour Induction

Ferring Pharmaceuticals announced on 17 October 2013, that its Misodel (misoprostol) removable, controlled-release vaginal delivery system for Labour Induction has successfully completed the European Decentralised Procedure involving 29 Member States of the European Economic Area (EEA). Each involved Member State should now adopt the decision and grant the national marketing authorisation, which may take from one to several months. Ferring plans to launch the product in the various European countries beginning in 2014.

Misodel in some European countries) has been approved for induction of labour in women with an unfavourable cervix, from 36 weeks of gestation, in whom induction is clinically indicated. An unfavourable cervix is a cervix that has not yet softened and thinned so that dilation can take place.

The decentralised submission was based on the results of clinical studies in more than 3,000 pregnant women at term, including the EXPEDITE study, a phase III, double-blind, randomised, multicentre study of 1,358 patients with an unfavourable cervix. The study compared the 200 mcg Misodel controlled release vaginal delivery system with the 10-mg dinoprostone vaginal insert (DVI), in terms of efficacy and safety. The EXPEDITE study showed that Misodel significantly reduced the time to vaginal delivery compared to DVI.