Ferring Pharmaceuticals have announced that its MISODELTM (misoprostol) removable, controlled-release vaginal delivery system for labour induction has successfully completed the European Decentralised Procedure.
MISODELTM 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 decentralized submission was based on the results of clinical studies in more than 3,000 pregnant women at term, including the EXPEDITE study2, a phase III, double-blind, randomised, multicentre study of 1,358 patients with an unfavourable cervix. The study compared the 200 mcg MISODELTM controlled release vaginal delivery system with the 10-mg dinoprostone vaginal insert (DVI), in terms of efficacy and safety. The EXPEDITE study showed that MISODELTM significantly reduced the time to vaginal delivery compared to DVI.
“Clinically indicated labour induction, that is when labour is induced to avoid risks to the pregnant woman or her child, is becoming a more common need in our clinical practice,” said Professor Tim Draycott, Consultant Obstetrician and Senior Clinical Lecturer, University of Bristol, UK. “We welcome this new formulation of misoprostol for vaginal delivery, which has proved to be an effective labour inducer and will be an important option we can offer our patients”.