Watson Pharmaceuticals, Inc. and Columbia Laboratories confirmed that Watson has received a complete response letter from the FDA for its New Drug Application 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 at ≤32 6/7 weeks gestation (P=0.022) did not meet the level of statistical significance generally expected to support the approval of the product in the U.S. market from a single trial. Although not part of the requirements communicated to the sponsor during pre-Phase 3 meetings, the FDA also raised the issue of robustness in efficacy in the U.S. sub-cohort as compared to the overall efficacy of the trial. In the complete response letter, FDA stated that additional clinical work would be required to support the approval.
Data submitted to the FDA in support of approval of the NDA 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 at ≤32 6/7 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 at ≤34 6/7 weeks gestation (P=0.012).
Progesterone vaginal gel 8% (Prochieve, Columbia Laboratories; Crinone, EMD Serono, Inc.) is indicated for progesterone supplementation or replacement as part of an Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency.
For more information, call (800) 272-5525 or visit www.watson.com.