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Data From Columbia Laboratories' Study for the Prevention of Preterm Birth to Be Presented at the Society for Maternal-Fetal Medicine (SMFM) 2008 Annual Meeting

Posted on: Thursday, 31 January 2008, 06:00 CST

Columbia Laboratories, Inc. (NASDAQ: CBRX) today announced that data relating to its previously reported prevention of preterm birth trial will be presented in an oral presentation at the SMFM 2008 Annual Meeting held in Dallas, Texas, from January 30, to February 2, 2008. The abstract was published in the 2007 December issue supplement of the American Journal of Obstetrics and Gynecology.

The following abstract will be presented in an oral session on January 31.

"Progesterone Reduces the Rate of Cervical Shortening in Women at Risk for Preterm Birth: Secondary Analysis from a Randomized, Double-Blind, Placebo-Controlled Trial" Dr. John O'Brien et al.

Summary: Progesterone's effect to reduce the rate of cervical shortening in women at risk for preterm birth is a possible mechanism for the observed reduction in births less than 32 weeks and the accompanying improvement in infant outcomes.

"The publication of these findings from Columbia Laboratories' prevention of preterm birth clinical trial reinforces the importance of studying the benefits of administering vaginal progesterone for the prevention of preterm birth in women with a short cervix," stated Robert S. Mills, Columbia's president and chief executive officer. "Currently there are no FDA-approved treatments available to prevent preterm birth and our recently initiated Phase III study in the prevention of preterm birth in women with a short cervix in mid-pregnancy is an example of our commitment to move our pipeline forward and address a serious unmet medical need. This natural progesterone product has a proven safety record in pregnant women and can be easily self-administered at home. We believe Prochieve® 8%, if approved for this new indication, will be an important drug in the fight against preterm delivery in women with a short cervix."

About Short Cervix

Women who have a cervical length of 3.0 centimeters or less when measured by transvaginal ultrasound in mid-pregnancy are at increased risk for preterm birth. It is estimated that 10% and 30% of pregnant women have a cervical length of less than 2.5 and 3.0 centimeters, respectively, when measured in mid-pregnancy.

About PROCHIEVE 8%

PROCHIEVE® 8% (progesterone gel) is FDA-approved for progesterone supplementation or replacement as part of Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency and for the treatment of secondary amenorrhea. Several trials showing these benefits have been published. PROCHIEVE 8% is safe for use during pregnancy, and has been safely used by tens of thousands of women globally to help sustain pregnancy at the early stages for ten years.

The most common side effects of PROCHIEVE 8% include breast enlargement, constipation, somnolence, nausea, headache, and perineal pain. PROCHIEVE 8% is contraindicated in patients with active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders, missed abortion, undiagnosed vaginal bleeding, liver dysfunction or disease, and known or suspected malignancy of the breast or genital organs.

For more information, please visit www.prochieve8.com.

About Columbia Laboratories

Columbia Laboratories, Inc. is a is a specialty pharmaceutical company focused on developing and marketing products for the women's healthcare and endocrinology markets using its novel bioadhesive drug delivery technology. Columbia markets CRINONE® 8% (progesterone gel) and PROCHIEVE® 8% (progesterone gel) in the United States for progesterone supplementation as part of an Assisted Reproductive Technology treatment for infertile women with progesterone deficiency. The Company also markets STRIANT® (testosterone buccal system) for the treatment of hypogonadism in men. The Company's research and development programs include a vaginal lidocaine product to prevent and treat dysmenorrhea and PROCHIEVE 8% to reduce the risk of preterm birth in women with a short cervix in mid-pregnancy. For more information, please visit www.columbialabs.com.

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This press release contains forward-looking statements about Columbia Laboratories, Inc.'s expectations regarding the Company's strategic direction, prospects and future results, and clinical research programs, which statements are indicated by the words "will,""plan,""expect" and similar expressions. Such forward-looking statements are subject to certain risks and uncertainties; actual results may 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 successful marketing of CRINONE® 8% (progesterone gel), PROCHIEVE® 8% (progesterone gel), and STRIANT® (testosterone buccal system) in the U.S.; the timely and successful development of new products, including vaginal lidocaine to prevent and treat dysmenorrhea, and new indications for current products, including PROCHIEVE 8% to reduce the risk of preterm birth in women with a short cervix in mid-pregnancy; the timely and successful completion of clinical studies, including the clinical studies for our vaginal lidocaine product candidate and the Phase III study of PROCHIEVE 8% in short cervix patients; success in obtaining acceptance and approval of new products and new indications for current products by the FDA and international regulatory agencies, the impact of competitive products and pricing; 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 Securities and Exchange Commission. Columbia Laboratories undertakes no obligation to publicly update any forward-looking statements.

CRINONE®, PROCHIEVE® and STRIANT® are registered trademarks of Columbia Laboratories, Inc.

Source: Business Wire

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