Ferring Pharmaceuticals bolstered its controlled-release, labor-induction delivery platform with Phase III data as the company awaits its approval from both European and U.S. authorities.
The Swiss company's misoprostol-releasing vaginal insert demonstrated that such a device significantly reduced the time it takes to deliver the drug, a synthetic prostaglandin that allows the cervix to open and contractions to start. Ferring's previous incarnation of the vaginal insert delivered the drug dinoprostone, but the recent Phase III results of misoprostol showed that the drug was much more effective, according to a release.
The study showed that in 1,358 women, some of whom received the new insert and others received dinoprostone, the median time for vaginal delivery was greatly diminished from 32.8 hours to 21.5 using the new device. European authorities accepted the submission in November, while the FDA accepted it a month earlier.
The new device tops the list of Ferring's line of obstetrics products, including the dinoprostone-delivering Propess and Cervidil inserts, the preterm labor treatment Tractocile and a number of treatments used to prevent hemorrhaging following cesarean section.
- here's the release