Crinone: Phase III data

Top-line data from the double-blind, international Phase III PREGNANT trial in 465 healthy pregnant women with a short cervical length showed that once-daily Prochieve 8% progesterone gel met the primary endpoint of significantly reducing the incidence of preterm birth at <=32 6/7 weeks gestation vs. placebo vaginal gel. The partners also said that there was evidence of improvement in infant outcome vs. placebo. Columbia said it plans to file an NDA for Prochieve to prevent preterm birth in 2Q11. ...