Ferring Presents Phase III Data for a Controlled Release Misoprostol Vaginal Delivery System for Labour Induction at the First European Congress on Intrapartum Care
AMSTERDAM--(BUSINESS WIRE)--Data from the EXPEDITE study presented today at the First European Congress on Intrapartum Care (ECIC) demonstrated that use of a controlled release misoprostol vaginal insert significantly reduced time to vaginal delivery compared to a dinoprostone vaginal insert.
"The increased incidence of labour induction has prompted the need for safe and more efficacious techniques and induction agents", said Dr. Deborah Wing, University of California, Irvine. "These results point toward significant efficacy advantages for the misoprostol vaginal delivery system".
Misoprostol is a synthetic prostaglandin E1 (PGE1) analogue. The World Health Organisation (WHO)2recommends 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 3,4.
The EXPEDITE study compared the efficacy and safety of a controlled release vaginal insert containing a reservoir of 200 µg of misoprostol (MVDS) versus a reservoir of 10 mg dinoprostone in a vaginal insert (DVI) when used for labour induction in a randomised phase III double-blinded study.
The research was done at over 30 sites across the USA where a total of 1,358 women were randomly assigned to receive either a single dose of MVDS (n=678) or dinoprostone vaginal insert (DVI) (n=680).
The co-primary efficacy endpoint of median time to vaginal delivery was found to be significantly shorter for women treated with MVDS compared with DVI (MVDS: 21.5 hours [95% CI: 20.0–23.4], DVI: 32.8 hours [95% CI: 30.2–34.9]; p<0.001). MVDS also decreased time to any delivery, time to active labour and pre-delivery oxytocin administration, compared with DVI.
The rates of caesarean delivery, co-primary safety endpoint, were not significantly different between MVDS and DVI (26.0% vs. 27.2%; p = 0.65). Furthermore, no significant differences between groups were observed in overall rates of neonatal treatment-emergent adverse events.
About labour induction
Labour induction has been increasingly used in obstetric practice over the last three decades. In Europe, the incidence of labour induction has risen from 10.4% to 20.5% (1981-1998)5. One explanation for the constantly rising rates of labour induction could be the increasing average maternal age at delivery across Europe. Induction of labour in older mothers is widely practiced as an intervention perceived to reduce the risk of late stillbirth6. For example, in the UK, the mean maternal age has increased dramatically over the past two decades, with statistics showing that between 1987 and 2008 pregnancies in women aged 35 and over rose from 8% to 20% and pregnancies in women aged 40 years and older trebled from 1.2% to 3.6%7. However, labour induction rates differ widely across Europe and the rise is not linear.
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.
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Tel: +41 58 301 00 00, Fax: +41 58 301 00 10, www.ferring.com