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news.Cytokine PharmaSciences has completed the Phase II study of the misoprostol vaginal insert (MVI), a proprietary, controlled-release and retrievable polymer chip containing prostaglandin E(1) (PGE1).
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Cytokine results of the dose-finding study in pregnant women at term gestation confirmed the efficacy and safety of its investigational product and suggested that the MVI may reduce time to delivery after induction, support more natural labor, and reduce the rate of cesarean delivery.
According to Cytokine, 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 US.
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).
The Phase III study in patients requiring cervical ripening and induction of labor is planned for second half of 2010.
Barbara Powers, vice president of clinical development at Cytokine PharmaSciences, said: “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. 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.”