Columbia Laboratories and Watson Announce Publication of Positive Phase III PROCHIEVEÃ‚® Vaginal Progesterone Gel Study Results
LIVINGSTON, N.J. and MORRISTOWN, N.J., April 6, 2011 /PRNewswire/ -- Columbia Laboratories, Inc. (Nasdaq: CBRX ), and Watson Pharmaceuticals, Inc. (NYSE: WPI ), today announced the publication of Phase III PROCHIEVE® (progesterone gel) data in today's online version of Ultrasound in Obstetrics & Gynecology, the leading peer-reviewed journal of the International Society of Ultrasound in Obstetrics & Gynecology.
The published results indicate that administration of vaginal progesterone from the midtrimester of pregnancy until term in women with a premature cervical shortening as confirmed by transvaginal ultrasound significantly reduced the rate of preterm birth before 33 weeks gestation (p=0.020). Use of PROCHIEVE was associated with a 45% reduction in the incidence of preterm birth before 33 weeks gestation. Further, improvement in infant outcome was noted with PROCHIEVE. Data published in the study also demonstrated that self-administered PROCHIEVE progesterone gel was associated with a significant reduction in the risk of preterm birth before 28 and before 35 weeks of gestation. Adverse events were comparable between women who received PROCHIEVE and those who received placebo. The publication will be available online at 10 a.m. EDT at http://onlinelibrary.wiley.com/journal/10.1002/(ISSN)1469-0705/accepted .
"The prevention of preterm birth is a major healthcare priority, and there are currently limited interventions available," said Roberto Romero, MD, Chief of the Perinatology Research Branch of NICHD/NIH and the Principal Investigator of the study. "Our data are the first to demonstrate that an intervention can dramatically reduce the rate of early prete