LIVINGSTON, N.J. - (Business Wire) In their American Society of Reproductive Medicine (ASRM) conference wrap-up, Medscape highlighted the article published by them on October 27, 2009, which summarized the results from the largest prospective, randomized clinical study to compare vaginal progesterone to intramuscular progesterone injections (IM progesterone) for luteal support in infertility treatment. The study demonstrated that CRINONE vaginal progesterone gel is equally effective and significantly better tolerated than IM progesterone for luteal phase support in In Vitro Fertilization and Embryo Transfer (IVF-ET) cycles. According to the Medscape article, quoting Paul W. Zarutskie, MD, an authority on luteal phase support in IVF from the Zarutskie Fertility and Endocrine Institute, “Last year, over 70% of the progesterone used in fertility and Ob/Gyn practices was intramuscular. However, I predict that in 2010 we will see vaginal administration as the preferred route of administration.” “I feel the time has come to change the paradigm for the administration of progesterone in luteal support and early pregnancy support to vaginal gel,” Dr. Zarutskie told Medscape.
Data from the study were presented by researchers from Brigham & Women’s Hospital in Boston at the annual meeting of the American Society for Reproductive Medicine (ASRM).
Lead investigator Elena Yanushpolsky, MD, assistant professor of obstetrics, gynecology and reproductive biology at Harvard Medical School, in Boston, Massachusetts, and Director, Reproductive Surgery, Center for Reproductive Medicine, Brigham & Women’s Hospital, told Medscape, “Intramuscular progesterone injections have been the standard form of luteal phase support in IVF for decades. IMP is considered painful and inconvenient and causes irritation of tissues, infections, and occasionally even more serious pulmonary complications, all of which have been reported in the literature. It was highly desirable to find an alternative more comfortable route of progesterone supplementation, but without compromise to pregnancy rates.”
In a press release issued last week, Dr. Yanushpolsky said the study data convinced her colleagues at Brigham & Women’s to switch their protocols for luteal phase support from intramuscular injections of progesterone to CRINONE for assisted reproductive technology (ART) cycles.
Medscape reported that in the study, over 400 participants were randomized to receive CRINONE (n=206) or IM progesterone (n=201), 48 or 24 hours after egg retrieval, respectively. No differences were observed between CRINONE and the IM progesterone groups in overall pregnancy rates, implantation, ongoing pregnancy or failed pregnancy rates. Patients were also surveyed at the completion of the cycle, and reported that CRINONE was significantly better tolerated than IM progesterone (4.4 versus 2.5 on a 5 point scale; p=0.0001).
Medscape’s article about the study was published by Emma Hitt, Ph.D., Medscape Medical News, October 27, 2009, and was entitled, “Progesterone Vaginal Gel as Effective, Better Tolerated Than Hormone Injections During IVF”. The study was supported in part by a grant from Columbia Laboratories, Inc. (Nasdaq: CBRX). Dr. Zarutskie also serves as a medical consultant to Columbia Laboratories, Inc.
About Progesterone and Luteal Phase Support
Progesterone is a hormone naturally found in a woman’s body, which creates a healthy environment in the uterus, where a fertilized egg can implant and grow into a healthy pregnancy. Most women undergoing infertility treatment need additional progesterone, to help prepare the uterus for implantation and development of a fertilized egg.
Before ovulation, progesterone levels in a woman’s body remain relatively low, but rise after ovulation, during the luteal phase. The luteal phase is the latter part of a woman’s menstrual cycle. It begins with the production of progesterone and ends with either pregnancy or menstruation, when the uterus sheds its lining. During pregnancy, progesterone helps to maintain the lining of the uterus, providing necessary nutrients to support and nurture a fertilized egg.
About CRINONE® 8%
CRINONE ® 8% was the first FDA-approved natural progesterone for progesterone supplementation or replacement as part of Assisted Reproductive Technology (ART) treatments for infertile women with progesterone deficiency, and is the only once a day treatment. CRINONE 8% is safe for use during pregnancy, and has been safely used for a decade by tens of thousands of women globally to help sustain pregnancy in the first trimester. Its unique bioadhesive delivery system provides controlled and sustained release of progesterone directly where it is needed. For more information, please visit www.crinoneusa.com.
The most common side effects of CRINONE 8% include breast enlargement, constipation, somnolence, nausea, headache, and perineal pain. CRINONE 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.
About Columbia Laboratories
Columbia Laboratories, Inc. is a specialty pharmaceutical company focused on developing and commercializing products for the women’s healthcare and endocrinology markets that use its novel bioadhesive drug delivery technology. Columbia’s U.S. sales organization markets CRINONE® 8% (progesterone gel) in the United States for progesterone supplementation as part of an Assisted Reproductive Technology treatment for infertile women with progesterone deficiency and STRIANT® (testosterone buccal system) for the treatment of hypogonadism in men. The Company’s partners market CRINONE® 8%, STRIANT® and three other products to additional U.S. and foreign markets.
The Company is conducting, in collaboration with the NIH, the PREGNANT (PROCHIEVE® Extending GestatioN A New Therapy) Study, a randomized, double blind, placebo controlled 450-patient Phase III clinical trial evaluating the ability of PROCHIEVE® 8% (progesterone gel) to reduce the risk of preterm birth in women with a cervical length between 1.0 and 2.0 centimeters as measured by transvaginal ultrasound at mid-pregnancy. The primary endpoint of the study is a reduction in the incidence of preterm birth at less than or equal to 32 weeks gestation vs. placebo.
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 involve 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 November 5, 2009, the date on which they were 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) and STRIANT® (testosterone buccal system) in the U.S.; the successful marketing of CRINONE® 8% by Merck Serono; the timely and successful development of PROCHIEVE® 8% to reduce the risk of preterm birth in women with a short cervix in mid-pregnancy; the timely and successful completion of the ongoing Phase III PREGNANT (PROCHIEVE® Extending GestatioN A New Therapy) Study of PROCHIEVE® 8% in short cervix patients; success in obtaining acceptance and approval of the short cervix indication for PROCHIEVE 8% by the U.S. Food and Drug Administration and international regulatory agencies; whether we elect to exercise our right to extend the balance due on the PharmaBio royalty agreement to 2011; our ability to obtain financing in order to fund our operations and repay our debt as it comes due; the impact of competitive products and pricing; the strength of the U.S. dollar relative to international currencies, particularly the Euro; 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.
PROCHIEVE®, CRINONE® and STRIANT® are registered trademarks of Columbia Laboratories, Inc.
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