Cytokine PharmaSciences, Inc. today announced the completion of a Phase II study of the misoprostol vaginal insert (MVI), a proprietary, controlled-release and retrievable polymer chip containing prostaglandin E(1) (PGE1). Results of the dose-finding study in pregnant women at term gestation confirm the efficacy and safety of this investigational product and suggest that the MVI may reduce time to delivery after induction, support more natural labor, and reduce the rate of cesarean delivery.
The randomized, double-blind, multi-center study tested three doses of the MVI in 374 women undergoing cervical ripening and induction of labor at 11 sites across the U.S. The MVI 200 reduced time to vaginal delivery by more than 9 hours (p < 0.018) compared to the lowest dose reservoir, MVI 100 (100 mcg reservoir). Oxytocin use was required in less than half the women tested with the MVI 200, and women exposed to this dose also spent an average of 8 hours less in the labor and delivery suite (both p < 0.001 compared to the MVI 100). Safety was primarily assessed by frequency of cesarean section. The rate of cesarean deliveries was 22.9% for the MVI 200 compared to 31.4% for the MVI 100 (p = 0.153). The MVI was well-tolerated at all doses with mostly mild and moderate adverse events. The most common adverse event was non-reassuring fetal heart rate; the frequency of this event was similar among the groups. Immediate neonatal outcomes were also similar across the three dose reservoirs tested and showed no safety signals of concern (median Apgar score of 9 at 5 minutes).
"We have now demonstrated that the MVI 200 led to a notable reduction in the rate of cesarean section in this population of induced women," said Barbara Powers, M.S.N., Ph.D., Vice President of Clinical Development at Cytokine PharmaSciences. "This may be the first time that a labor induction product has been shown not only to reduce time to delivery, but may also reverse the recent, disturbing trend of the rising rate of cesarean deliveries. In addition, avoiding oxytocin in more than 50% of induced women allowed the MVI 200 to mimic the spontaneous labor process and more naturally lead into labor by gradually inducing contractions."
A Phase III study in patients requiring cervical ripening and induction of labor is planned for 2H 2010.
SOURCE Cytokine PharmaSciences, Inc.