MORRISTOWN, N.J. — An investigational drug made by Watson Pharmaceuticals and Columbia Labs reduced the risk of premature birth, according to results of a late-stage clinical trial.
The two companies announced results Monday of a phase-3 trial of Prochieve (progesterone), a vaginal gel, saying that it produced a significant reduction in the number of preterm births. The trial was conducted under a collaboration with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, part of the National Institutes of Health.
“The primary result of this trial shows that vaginal progesterone reduces the rate of spontaneous preterm birth,” chief of the NICHD’s perinatology research branch Roberto Romero said. “Preterm birth is a serious public health problem, affecting 10% to 12% of all pregnancies in the United States and costing approximately $26 billion per year.”