Phase 2 study of misoprostol vaginal insert (MVI) for labor induction

Cytokine PharmaSciences announced the completion of its Phase 2 study of the misoprostol vaginal insert (MVI) for cervical ripening and induction of labor. This 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 misoprostol vaginal insert (MVI) is a proprietary, controlled-release and retrievable polymer chip containing prostaglandin E(1) (PGE1). This delivery system controls the gradual release of misoprostol, a potent cervical ripening and labor induction agent.

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