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Columbia Laboratories and Watson Pharmaceuticals has confirmed that the Advisory Committee for Reproductive Health Drugs of the U.S. Food and Drug Administration (FDA) 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.
While panel members generally agreed that progesterone vaginal gel 8% is safe, the panel stated that more information is needed to support approval. While the FDA will consider recommendations of the Committee, the final decision regarding the approval of the product rests solely with the FDA. The FDA’s Division of Reproductive and Urologic Products is expected to take action on Columbia’s New Drug Application (NDA) by February 26, 2012.
“We will work with the FDA to address the Advisory Committee’s comments as the Agency finalizes its review of our NDA. We remain confident in the PREGNANT study results that showed the administration of progesterone vaginal gel 8% is a safe and effective treatment for patients at risk for preterm birth due to short uterine cervical length in the mid-trimester of pregnancy. We hope the agency’s final decision will acknowledge the clear unmet medical need in this patient population,” said Frank Condella, President and CEO of Columbia Laboratories.
“As was highlighted today, 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,” saidFred 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 Committee evaluated data submitted by Columbia to the FDA in its New Drug Application (NDA 22-139), 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).
In the pregnant study, the frequency of maternal treatment-emergent adverse events both overall and by individual event was comparable between the placebo and progesterone vaginal gel treatment groups.
The most frequent events in the progesterone vaginal gel group were expected complications of a high-risk pregnancy and included “premature baby” (19%), “uterine contractions abnormal” (14%), “premature labor” (7%). “Cervical disorder” (10%), “nausea” (10%), “headache” (7%), and “vulvo vaginal mycotic infection” (7%) were also reported.
The Advisory Committee for Reproductive Health Drugs is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of reproductive conditions and makes non-binding recommendations to the FDA.