FDA issues complete response letter for Watson's progesterone vaginal gel 8% NDA

Watson Pharmaceuticals, Inc. (NYSE: WPI) and Columbia Laboratories, Inc. (Nasdaq: CBRX) today confirmed that, as expected, Watson has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA 22-139) for progesterone vaginal gel 8% for use in the reduction of risk of preterm birth in women with a singleton gestation and a short uterine cervical length in the mid-trimester of pregnancy. 

The complete response letter stated that the effect of treatment with progesterone vaginal gel 8% in reducing the risk of preterm birth in women with a short uterine cervical length.

On February 10, 2012, Columbia transferred NDA 22-139 to Watson.  Watson now has full rights and regulatory responsibility for all activities and sponsor obligations relating to this application. 

"Watson will work directly with the FDA to address items raised in the complete response letter regarding the approvability of progresterone vaginal gel 8% for reduction of preterm birth. We have formally requested an end of review meeting with FDA to determine if a viable path forward can be established for this application," said Paul M. Bisaro, Watson President and CEO.  "We believe that there is a significant unmet medical need for a safe and effective treatment of patients at risk for preterm birth which affects approximately one-in-eight live-born infants in the U.S."

Data submitted to the FDA in support of approval of NDA 22-139 included results from the PREGNANT study, which showed that women with a short uterine cervical length as measured by trans-vaginal ultrasound between 19 and <24 weeks of gestation who were treated with progesterone vaginal gel 8% had a significantly lower risk of preterm birth.

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.