U.K. 13 October 2014 – Ferring Pharmaceuticals Ltd, U.K. announced today that the Scottish Medicines Consortium (SMC) has accepted its new product MYSODELLE® (misoprostol), a retrievable, controlled-release vaginal insert for use in NHS Scotland. MYSODELLE is indicated for the induction of labour in women with an unfavourable cervix*, from 36 weeks of gestation, in whom induction is clinically indicated.
MYSODELLE was approved via a European Decentralised Procedure involving 29 Member States of the European Economic Area (EEA) based on the results of the pivotal EXPEDITE study1. The Medicines and Healthcare products Regulatory Agency (MHRA) adopted the decision and granted a National Marketing Authorization in November 2013.
MYSODELLE has been specifically developed and approved for labour induction and it is the only licensed controlled-release, retrievable insert containing misoprostol. The decision made by the SMC marks an important step in enhancing the care and experience of women who are being induced for labour.
UK General Manager of Ferring Pharmaceuticals, Steve Howson said, “We are excited to launch our controlled-release formulation of misoprostol for labour induction, a procedure which is becoming increasingly common in the UK. This introduction demonstrates Ferring’s ongoing commitment to develop new and clinically significant treatments in the field of reproductive health and obstetrics”.
“Many maternity units are stretched with limited midwifery and physical bed capacity which sometimes lead to temporary closures of delivery suites. MYSODELLE could potentially help relieve some of the pressures on midwifery time and bed capacity.”
“The misoprostol vaginal insert is an important development to help manage the induction of labour for many of our couples, especially those who experience prolonged inductions, said Kirsty Dundas, Consultant Obstetrician, Royal Infirmary of Edinburgh. “The treatment should help improve our processes and provide a better service with its much quicker time to delivery.”
As well as reviewing the clinical and safety evidence for MYSODELLE, the SMC reviewed the comparative health economic evidence and stated that the economic case for MYSODELLE has been demonstrated.
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MYSODELLE consists of a single administration, retrievable controlled-release vaginal insert with a dosing reservoir of 200 micrograms of misoprostol. Misoprostol is released at a mean rate of approximately 7 micrograms/hour over a period of 24 hours. Drug release continues as long as MYSODELLE® is in the vagina. The product is equipped with a retrieval tape that enables rapid removal.
Misoprostol is a synthetic prostaglandin E1 (PGE1) analogue. The World Health Organization (WHO) recommends prostaglandins for cervical ripening and labour induction and misoprostol is one of the compounds on the “WHO essential drug list” for labour induction. Many current clinical guidelines also recommend the use of prostaglandins for the induction of labour.4,7 The NICE UK guidelines currently recommend vaginal PGE2 as the preferred method of induction of labour.
About the EXPEDITE study
The decentralised submission was based on the results of clinical studies in more than 3,000 pregnant women at term, including the EXPEDITE study.1 It was a phase III, randomized, double-blind, multicentre study conducted in the U.S., which compared the 200mcg misprostol vaginal insert (MVI) (n=678) with the 10-mg dinoprostone vaginal insert (DVI) (n=680) in terms of efficacy and safety in induction of labour in pregnant women with an unfavourable cervix.
Women treated with MVI (misoprostol) had significantly shorter median time to vaginal delivery (primary endpoint) than the women treated with DVI (21.5 hours [95% CI: 20.0–23.4] vs 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 vs 27.3h, p<0.001) and overall median time to onset of active labour (12.1h vs 18.6h p<0.001) compared with the women treated with DVI. Fewer women treated with MVI received pre-delivery oxytocin (48.1% vs 74.1% p<0.001).
The rates of caesarean delivery, co-primary safety endpoint, were similar between MVI and DVI (26.0% vs. 27.2%; p = 0.65).
About labour induction
Labour induction is defined as the artificial initiation of labour.8 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 the UK, the incidence of labour induction has increased to approximately 20% of all pregnancies.8 One possible explanation for this trend is the association between increased maternal age and complication rates.8 In the U.K. vaginal PGE2 is the preferred pharmacological method for induction of labour.4 Prostaglandins have been shown to be efficacious in both cervical ripening and labour induction. Several clinical guidelines recommend prostaglandins for use in labour induction.2,3,4 If vaginal PGE2 is contraindicated for any reason, amniotomy (alone or with oxytocin) may be offered4.Membrane sweeping is regarded as an adjunct to the process of induction of labour. It involves the examining finger passing through the cervix to rotate against the wall of the uterus, to separate the chorionic membrane from the deciduas.4
About Ferring Pharmaceuticals
Headquartered in Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The Ferring product portfolio demonstrates an exceptionally innovative and successful track record in the fields of Urology, Endocrine Oncology, Gastroenterology, Endocrinology (Growth) and Reproductive Health (Infertility and Obstetrics). The common thread is that the Company remains focused on producing treatments that enable doctors to treat patients on the body's own terms. Ferring has its own operating subsidiaries in 55 countries and markets its products in more than 100 countries. For more information visit www.ferring.co.uk.
* An unfavourable cervix is a cervix that has not yet softened and thinned so that dilation can take place.
For further information please contact:
General Manager, Ferring Pharmaceuticals (UK) Ltd.
+44 208 580 4199
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1. Wing DA, Brown R, Plante LA et al. Misoprostol Vaginal Insert and Time to Vaginal Delivery. A randomized Controlled Trial. Obstet Gynecol 2013; 122: 201-9. Web address:
2. Kjaergaard H, Foldgast AM, Dykes AK. Experiences of non-progressive and augmented labour among nulliparous women: a qualitative interview study in a Grounded Theory approach. BMC Pregnancy Childbirth. 2007;7:15
3. Cheng YW, et al. Obstet Gynecol 2010;116:1127-1135. (PubMed)
4. NICE Clinical guidelines – Induction of labour, July 2008.
5. ACOG practice Bulletin – Induction of labour, August 2009.
6. WHO Recommendation for Induction of labour, 2011.
7. SOGC Clinical practice Guideline Induction of Labour, 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