The US Food and Drug Administration (FDA) has accepted to review Ferring Pharmaceuticals' new drug application (NDA) of controlled release misoprostol vaginal insert (MVI) for decreasing time to vaginal delivery in women with an unfavorable cervix.
The NDA included the data of clinical studies in more than 3,000 pregnant women at term including the EXPEDITE study.
The 1,358 patient-based double blind, randomized, multicenter EXPEDITE Phase 3 study evaluated the efficacy and safety of Ferring's controlled release removable MVI versus CERVIDIL (dinoprostone).
The study showed that MVI decreased the time to vaginal delivery in women with an unfavorable cervix compared to CERVIDIL.
Ferring Pharmaceuticals president and COO Aaron Graff said the company is pleased with the FDA's acceptance of the NDA submission for its controlled release misoprostol vaginal insert.
"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," Graff added.
"We look forward to collaborating with the FDA on its review of our NDA."
