Ferring's European Marketing Authorisation Application for controlled release misoprostol vaginal delivery system for the induction of labour accepted for review
Saint-Prex, Switzerland, 5 November 2012 – 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.
"We are pleased by the action of European authorities in accepting the Marketing Authorisation Application for review for Ferring's controlled release, removable misoprostol vaginal delivery system," said Pascal Danglas, Executive Vice President, Clinical and Product Development, Ferring Pharmaceuticals. "Among expectant mothers, labour induction is an increasingly common clinical indication. Ferring is committed to developing new and improved treatments in the area of reproductive health. We look forward to cooperating with the review process."
- ENDS -
About Labour Induction
Labour induction is an increasingly common obstetric intervention, with more than 20 percent of births now being induced.
The need for labour induction occurs when delivery of the baby is necessary, for a variety of reasons, prior to the start of a natural labour. The induction process requires the uterus to be stimulated to contract in an effort to have a vaginal birth. Additionally, it can involve the need for cervical ripening which is when the cervix is deemed as being "unfavourable" or when the tissue needs to soften, thin and dilate. This can be achieved through either pharmacological or mechanical means.
About Ferring's Controlled Release Misoprostol Vaginal Delivery System (MVDS)
Ferring's controlled release removable misoprostol vaginal insert is an investigational vaginal delivery system containing misoprostol. In the EXPEDITE Study, the MVDS was given as a single dose, with continuous, controlled release of misoprostol for up to 24 hours. The U.S. Food and Drug Administration (FDA) has also accepted for review Ferring's New Drug Application (NDA) for the MVDS. The MVDS was developed by Ferring Controlled Therapeutics Ltd. a wholly-owned member of the Ferring Group based in East Kilbride, Scotland.
About Ferring Pharmaceuticals
Headquartered in Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology and endocrinology. Ferring has its own operating subsidiaries in 50 countries and markets its products in more than 90 countries. To learn more about Ferring or its products please visit www.ferring.com.
*The EXPEDITE Study: A phase III, double blind, randomized, multicenter study of EXogenous Prostaglandin comparing the Efficacy and safety of the Misoprostol Vaginal Insert (MVI) 200 mcg to the Dinoprostone vaginal Insert for reducing Time to vaginal delivery in pregnant women at tErm
**CERVIDIL® (dinoprostone) is a registered trademark of Ferring, except in the U.S. where it is a trademark of Forest Laboratories, Inc.
For further information, contact:
Patrick Gorman
Tel: +41 (0) 58 301 00 53
[email protected]