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Columbia Laboratories and Watson Announce Publication of Positive Phase III PROCHIEVE® Vaginal Progesterone Gel Study Results
Date:4/6/2011

were treated with placebo (p=0.020).  A reduction in the risk of preterm birth was observed in both women with and without a prior history of preterm birth.  PROCHIEVE was also associated with a significant reduction in the risk of preterm birth before 28 and 35 weeks gestation (p=0.036 and 0.016, respectively).

Neonatal Infant SafetyNeonatal safety outcomes were also evaluated for PROCHIEVE as compared to placebo. Incidences of neonatal morbidity, respiratory distress syndrome, bronchopulmonary dysplasia, grade III or IV intraventricular hemorrhage, periventricular leukomalacia, proven sepsis, necrotizing enterocolitis and perinatal mortality (fetal death or neonatal death) were measured.  Four composite outcome scores were also used to assess prenatal mortality and neonatal morbidity.  Data showed strong trends favoring PROCHIEVE.

PROCHIEVE was well tolerated in the trial.  Adverse events were comparable between women who received PROCHIEVE and those who received placebo.  The most frequently reported adverse events related to study treatment occurred in 2% of women and included vaginal pruritus, vaginal discharge, vaginal candidiasis and nausea. Furthermore, no fetal or neonatal safety signal was detected for women treated with PROCHIEVE.

This study was conducted in collaboration with the Perinatology Research Branch (PRB) of the Division of Intramural Research of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH).

About Preterm BirthOccurring in one in eight live births, preterm birth is a leading cause of perinatal morbidity and mortality worldwide and its prevention is an important healthcare priority. The economic impact of preterm birth is significant, costing more than $26 billion annually, with the average preterm infant costing approximately $52,000.

The newborn complications associated with p
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SOURCE Watson Pharmaceuticals, Inc.; Columbia Laboratories, Inc.
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