Ferring Pharmaceuticals' European Marketing Authorization Application for Controlled Release Misoprostol Vaginal Delivery System for the Induction of Labor Accepted for Review
11/5/2012 10:54:43 AM
SAINT PREX, Switzerland--(BUSINESS WIRE)--Ferring Pharmaceuticals announced today that it has received confirmation from European health authorities that the Marketing Authorisation Application (MAA) for its controlled release, removable misoprostol vaginal delivery system (MVDS) has been accepted for review under the decentralised procedure. Ferring is seeking approval for the MVDS for induction of labour in women with an unfavourable cervix, from 36 weeks gestation, in whom induction is clinically indicated. The submission was based on the results of clinical studies in more than 3,000 pregnant women at term including the EXPEDITE Study*, a Phase 3, double blind, randomized, multicenter study of 1,358 patients at 35 U.S. study sites. The study evaluated the efficacy and safety of Ferring’s controlled release removable MVDS versus CERVIDIL®** (dinoprostone) and the results showed that MVDS decreased the time to vaginal delivery in women with an unfavourable cervix compared to CERVIDIL. An unfavourable cervix is a cervix that has not yet softened and thinned so that dilation can take place.