The FDA’s advisory committee for Reproductive Health Drugs did not recommend approval of progesterone vaginal gel 8% for the reduction of risk of preterm birth in women with short uterine cervical length at the mid-trimester of pregnancy, confirmed Columbia Laboratories and Watson Pharmaceuticals.

While panel members generally agreed that progesterone vaginal gel 8% is safe, the panel said more information is needed to support approval. The FDA will consider recommendations of the advisory committee, but the final decision rests solely with the FDA.

"There are currently no products approved to reduce the risk of preterm birth in women with premature cervical shortening—an established strong predictor of preterm birth risk," said Fred Wilkinson, Watson's executive vice president, global brands.  "The availability of a safe and effective product, with a demonstrated ability to reduce the risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy would represent a significant advance in the prevention of early preterm birth and its associated complications."

The advisory committee evaluated data submitted by Columbia to the FDA in its New Drug Application, which includes data from two phase III clinical trials.  One of these trials, the PREGNANT study, showed that women with a short uterine cervical length as measured by transvaginal ultrasound between 19 and 24 weeks of gestation who were treated with progesterone vaginal gel 8% had a significantly lower risk of preterm birth before 33 weeks gestation compared to those who were treated with placebo (p=0.022). This study included women with and without a prior history of preterm birth.  Progesterone vaginal gel 8% was also associated with a significant reduction in the risk of preterm birth before 35 weeks gestation (p=0.012).

Columbia Laboratories president and CEO Frank Condella said the company will work with the FDA to address the advisory committee's comments as the FDA finalizes its review.