LIVINGSTON and PARSIPPANY, N.J. — A drug designed to reduce the risk of premature birth among pregnant women has been submitted to the Food and Drug Administration for approval.
Columbia Labs and Watson Pharmaceuticals announced the submission of a new drug application for Prochieve (progesterone gel), which seeks to reduce the risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy. The NDA submission included data from two phase-3 clinical trials evaluating the use of Prochieve in reducing the risk of preterm birth in women, as well as supportive pharmacokinetic studies.
Columbia Labs said that it has requested priority review from the FDA, which would shorten the review process to six months, versus 10 months for standard review.
"Premature cervical shortening is a powerful predictor of risk for preterm delivery. At present, there are no widely accepted interventions to address this medical need," said Frank Condella, Columbia Labs president and CEO. "The recently published 'PREGNANT' study has demonstrated that the use of Prochieve can significantly reduce the incidence of early preterm birth in women with a short cervix at mid-pregnancy, and the study also provided evidence of improvement in infant outcome."
Watson acquired the rights of progesterone products from Columbia Labs last year.