Meta-analysis of Five Clinical Trials including Columbia Laboratories' PREGNANT Study Published in American Journal of Obstetrics and Gynecology
LIVINGSTON, N.J.--(BUSINESS WIRE)--Dec 14, 2011 - Columbia Laboratories, Inc. (Nasdaq: CBRX) announced today that a meta-analysis of data from five double-blind, placebo-controlled trials of vaginal progesterone, including the PREGNANT study, Columbia's pivotal clinical trial of progesterone vaginal gel 8% to reduce the risk of preterm birth in women with premature cervical shortening, found that administering vaginal progesterone to asymptomatic women with a sonographic short cervix in the mid-trimester of pregnancy significantly reduces the risk of preterm birth and neonatal morbidity.
The meta-analysis is now available via open access (free of charge) at http://www.ajog.org/article/S0002-9378(11)02358-1/abstract, and will be published in the American Journal of Obstetrics and Gynecology, the journal of the Society for Maternal-Fetal Medicine (SMFM).
Roberto Romero, M.D., Chief of 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), was the Principal Investigator of the meta-analysis, which evaluated the efficacy and safety of vaginal progesterone for the prevention of preterm birth and neonatal morbidity and mortality in asymptomatic women with a sonographic short cervix (‰¤25 mm) in the mid-trimester of pregnancy. Five trials of high quality were included, with a total of 775 women and 827 infants. Treatment with vaginal progesterone was associated with a significant reduction in the rate of preterm birth at <33 weeks, <35 weeks and <28 weeks, respiratory distress syndrome, composite neonatal morbidity and mortality, birth weight <1500 g, admission to NICU, and requirement for mechanical ventilation. There were no significant differences between the vaginal progesterone and placebo groups in the rate of adverse maternal events or congenital anomalies.
About American Journal of Obstetrics and Gynecology
Covering the full spectrum of the specialty, the American Journal of Obstetrics and Gynecology (the “Gray Journal”) presents the latest diagnostic procedures, leading-edge research, and expert commentary in maternal-fetal medicine, reproductive endocrinology and infertility, and gynecologic oncology as well as general obstetrics and gynecology.
About the PREGNANT Study
The PREGNANT (PROCHIEVE Extending GestatioN A New Therapy) study was conducted collaboratively under a Clinical Trials Agreement between Columbia and the PRB/NICHD/NIH to evaluate the safety and efficacy of progesterone vaginal gel 8% to reduce the risk of preterm birth in women with a short cervical length as measured by transvaginal ultrasound at mid-pregnancy. This double-blind, placebo controlled study enrolled 465 healthy pregnant women between the ages of 15 and 45 at more than 40 sites in 10 countries. Nearly half of the subjects were enrolled in the U.S. Subjects were randomly assigned to receive either progesterone vaginal gel 8% or placebo vaginal gel once daily until the earlier of 37 weeks gestation or delivery.
The published results indicate that the administration of progesterone vaginal gel 8% from the midtrimester of pregnancy until term in women with a premature cervical shortening was associated with a statistically significant 45% reduction in the incidence of preterm birth before 33 weeks gestation. In addition, improvement in infant outcome was noted with progesterone vaginal gel 8%. Self-administered progesterone vaginal gel 8% was also 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 progesterone vaginal gel 8% and those who received placebo.
About Columbia Laboratories
Columbia Laboratories, Inc. is developing products that utilize its novel bioadhesive drug delivery technologies to optimize drug delivery in a controlled, sustained manner. The Company has developed and sold six products for the U.S. market including CRINONE® (progesterone gel), for which Columbia receives royalties on annual net sales from Watson Pharmaceuticals. CRINONE is commercialized outside the U.S. by Merck Serono. The Company's New Drug Application (NDA) for progesterone vaginal gel 8% for 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 was accepted for filing by the Food and Drug Administration (FDA) with a PDUFA date of February 26, 2012. The NDA is scheduled to be discussed by the Advisory Committee for Reproductive Health Drugs of the FDA on January 20, 2012.
Columbia's press releases and other company information are available online at www.columbialabs.com.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This communication contains forward-looking statements, which statements are indicated by the words “may,” “will,” “plans,” “believes,” “expects,” “anticipates,” “potential,” and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. Factors that might cause future results to differ include, but are not limited to, the following: the outcome of further analyses by the FDA of the clinical data in the Preterm Birth NDA, including the adequacy of demonstration of efficacy in the U.S. population; success in obtaining timely approval of the Preterm Birth NDA by the FDA; the timing and level of success of a future product launch, if any; the ability of Columbia's third-party manufacturers to supply CRINONE®; successful compliance with FDA and other governmental regulations applicable to manufacturing facilities, products and/or businesses; the ability to obtain and enforce patents and other intellectual property rights; the impact of competitive products and pricing; the timely and successful negotiation of partnerships or other transactions; the strength of the United States dollar relative to international currencies; competitive economic and regulatory factors in the pharmaceutical and healthcare industry; general economic conditions; and other risks and uncertainties that may be detailed, from time-to-time, in Columbia's reports filed with the SEC. Columbia does not undertake any responsibility to revise or update any forward-looking statements contained herein.
CRINONE® is a registered trademark of Watson Pharmaceuticals, Inc.
Contact: Columbia Laboratories, Inc.
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Posted: December 2011