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Ferring Pharmaceuticals Announces FDA Acceptance of NDA Filing for Controlled Release Misoprostol Vaginal Insert for Decreasing Time to Vaginal Delivery in Women


10/23/2012 10:29:03 AM

PARSIPPANY, N.J., Oct. 23, 2012 /PRNewswire/ -- Ferring Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for its controlled release misoprostol vaginal insert (MVI). Ferring is seeking approval for the MVI for decreasing time to vaginal delivery in women with an unfavorable cervix (a cervix that has not yet softened and thinned so that dilation can take place) when used in sequential regimen with oxytocin augmentation, if needed.

The NDA 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 MVI versus CERVIDIL®** (dinoprostone) and determined that the study reported MVI decreased the time to vaginal delivery in women with an unfavorable cervix compared to CERVIDIL.

"We are pleased with the FDA's acceptance of the NDA submission for Ferring's controlled release misoprostol vaginal insert," said Aaron Graff, President and COO of Ferring Pharmaceuticals Inc. "We are dedicated to advancing new treatments in the field of women's health and obstetrics and are proud to bring one of the first new advancements in obstetrics in over 15 years. We look forward to collaborating with the FDA on its review of our NDA."

About Labor Induction

Labor induction is an increasingly common obstetric intervention, with more than 20 percent of births now being induced.

The need for labor induction occurs when delivery of the baby is necessary, for a variety of reasons, prior to the start of a natural labor. 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 "unfavorable" 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 Insert

Ferring's controlled release removable misoprostol vaginal insert (MVI) is an investigational vaginal delivery system containing misoprostol. In the EXPEDITE Study, the MVI was given as a single dose, with continuous, controlled release of misoprostol for up to 24 hours. Marketing Authorisation Application for the MVI has also been submitted in the EU.

About Ferring Pharmaceuticals Inc.
Ferring Pharmaceuticals Inc. is a subsidiary of Ferring Pharmaceuticals, a privately owned, international pharmaceutical company. Ferring Pharmaceuticals specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, gastroenterology, infertility, obstetrics/gynecology, orthopaedics and urology. For more information, call 1-888-FERRING (1-888-337-7464); visit www.FerringUSA.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 Forest Laboratories, Inc.

SOURCE Ferring Pharmaceuticals Inc.



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