PROCHIEVE 8% to Reduce the Risk of Preterm Birth in Women with a Short Cervix
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In April 2007, we reported that data from the Phase III clinical trial of PROCHIEVE 8% (progesterone gel) for the prevention of preterm birth in women with a prior preterm birth earlier than 35 weeks show a delay in cervical shortening in patients treated with PROCHIEVE 8% versus placebo. A short cervix is a known indicator of increased risk for preterm birth. The data further suggest a correlation between the cervical length data, progesterone administration, and both a reduction in the likelihood of preterm birth and an improvement in infant outcomes. Related press release. We plan to meet with the U.S. Food and Drug Administration in July 2007 to explore the clinical and regulatory path for PROCHIEVE 8% to prevent preterm birth in short cervix patients.
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