SAINT-PREX, Switzerland--(BUSINESS WIRE)--Ferring Pharmaceuticals announced today that its MISODELTM (misoprostol) removable, controlled-release vaginal delivery system for labour induction has successfully completed the European Decentralised Procedure involving 29 Member States1 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.
MISODELTM (MYSODELLETM 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 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”.
“We are very happy with the decision of the European Health Authorities to approve our new formulation of misoprostol for labour induction, which enables controlled-release delivery of the drug in the vagina,” said Dr. Pascal Danglas, Executive Vice President, Clinical and Product Development at Ferring Pharmaceuticals. “Ferring is committed to developing new and improved treatments in the area of reproductive health, where it has been active for decades. We look forward to making this new product available to obstetricians and the growing number of patients for whom labour induction is clinically indicated”.
MISODELTM consists of a single application, removable controlled release vaginal delivery system with a reservoir of 200 mcg of misoprostol. Misoprostol is released at a mean rate of approximately 7 mcg/hour over a period of 24 hours. Drug release continues as long as MISODELTM is in the vagina. The product is equipped with a withdrawal tape that facilitates rapid removal when active labour begins.
Misoprostol is a synthetic prostaglandin E1 (PGE1) analogue. The World Health Organisation (WHO) recommends prostaglandins for labour induction3 and misoprostol is one of the compounds on the “WHO essential drug list” for labour induction. Most current clinical guidelines also recommend the use of prostaglandins for labour induction2,4,5.
About the EXPEDITE study
The EXPEDITE study2 was a phase III, randomized, double-blind, multicentre study , which compared 200 mcg MISODELTM (n=678) with the 10-mg dinoprostone vaginal insert (DVI) (n=680) in terms of efficacy and safety in the induction of labour in pregnant women with an unfavourable cervix. An unfavourable cervix is a cervix that has not yet softened and thinned so that dilation can take place.
Women treated with MISODELTM (misoprostol) had significantly shorter median time to vaginal delivery (primary endpoint) than women treated with DVI (21.5 hours [95% CI: 20.0–23.4] versus 32.8 hours [95% CI: 30.2–34.9]; p<0.001, respectively). They also had significantly decreased overall median time to any delivery (18.3h versus 27.3h, p<0.001) and overall median time to onset of active labour (12.1h versus 18.6h p<0.001) compared with the women treated with DVI. Fewer women treated with MISODELTM received pre-delivery oxytocin (48.1% vs 74.1% p<0.001).
The rates of caesarean delivery, co-primary safety endpoint, were similar between MISODELTM and DVI (26.0% versus. 27.2%; p = 0.65).
About labour induction
Labour induction is defined as the artificial initiation of labour4. It is generally indicated when the risk to either the mother or the foetus outweighs the possible benefits of continuing to manage the pregnancy. In developed countries, the incidence of labour induction has increased to approximately 20% of all pregnancies6,7. One possible explanation for this trend is the association between increased maternal age and complication rates8.
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 55 countries and markets its products in more than 100 countries. To learn more about Ferring or its products please visit www.ferring.com.
All trademarks mentioned above are property of Ferring B.V.
Ferring International Center S.A., Chemin de la Vergognausaz 50, 1162
Tel: +41 58 301 00 00, Fax: +41 58 301 00 10, www.ferring.com
1 Austria, Belgium, Bulgaria, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Lithuania, Latvia, Luxembourg, Malta, the Netherlands,
Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and
2 Wing DA, Brown R, Plante LA, Miller H, Rugarn O, Powers BL. Misoprostol vaginal insert and time to vaginal delivery: a randomized controlled trial. Obstet Gynecol 2013; 122 (2 Pt 1): 201-9
3 World Health Organization. Managing complications in pregnancy and childbirth. A guide for midwives and doctors (2007). Available from: http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/9241545879/en/index.html. Accessed April 2013.
4 RCOG & NICE. Induction of Labour Clinical Guideline (2008). Available at: http://www.nice.org.uk/nicemedia/live/12012/41255/41255.pdf. Accessed May 2013.
5 ACOG. Obstet Gynecol 2009;114:386–97.
6 Blondel B, Kermarrec M. Les NAISSANCES en 2010 et leur évolution depuis 2003. Unité de recherche épidémiologique en santé périnatale et santé des femmes et des enfants. INSERM 2011;U.953.
7 RCOG & NICE. Induction of Labour Clinical Guideline (2008). Available at: http://www.nice.org.uk/nicemedia/live/12012/41255/41255.pdf. Accessed September 2013.
8 Carolan M, Davey MA, Biro MA, Kealy M. Older Maternal Age and Intervention in Labor: A Population-Based Study Comparing Older and Younger First-Time Mothers in Victoria, Australia. Birth 2011;38:24–9. Available at http://www.ncbi.nlm.nih.gov/pubmed/?term=Carolan+M%2C+Davey+MA%2C+Biro+MA%2C+Kealy+M.+Older+Maternal+Age+and+Intervention+in+Labor%3A+A+Population-Based+Study+Comparing+Older+and+Younger+First-Time+Mothers+in+Victoria%2C+Australia.+Birth. Accessed September 2013.