NDA Accepted for Controlled Release Misoprostol Vaginal Insert for Decreasing Time to Vaginal Delivery
Ferring Pharmaceuticals announced that the FDA has accepted for review a New Drug Application (NDA) for its controlled release misoprostol vaginal insert (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 (Pitocin; JHP Pharmaceuticals), 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 vs. Cervidil (dinoprostone; Forest Laboratories) and determined that the study reported MVI decreased the time to vaginal delivery in women with an unfavorable cervix compared to Cervidil.
Ferring's controlled release removable MVI is an investigational vaginal delivery system containing misoprostol, a potent cervical ripening and labor induction agent.
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