Columbia Laboratories, Inc. (CBRX), and Watson Pharmaceuticals, Inc. (WPI) announced that the Advisory Committee for Reproductive Health Drugs of the U.S. Food and Drug Administration or FDA declined to 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.
Both the companies noted that while panel members agreed that progesterone vaginal gel 8% is safe, the panel stated that more information is needed to support approval.
The company added that as 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 or NDA by February 26, 2012.
Further, the Committee evaluated data submitted by Columbia to the FDA in its New Drug Application, which includes data from two Phase III clinical trials.
The company stated that 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.="" this="" study="" included="" women="" with="" and="" without="" a="" prior="" history="" of="" preterm="" birth.="">
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