For the first time, data show a positive association between the use of vaginal progesterone and infants' overall health at birth. Babies born to women with high-risk pregnancies treated with PROCHIEVE(R) 8% (progesterone gel) appear to be less likely to need intensive care than babies born to mothers treated with placebo, Columbia Laboratories, Inc. (NASDAQ:CBRX) announced today. The data are published in the October issue of Ultrasound in Obstetrics & Gynecology (also known as The White Journal), the official publication of the International Society of Ultrasound in Obstetrics and Gynecology.
LIVINGSTON, N.J. (Business Wire EON) October 4, 2007 --
For the first time, data show a positive association between the use of
vaginal progesterone and infants’ overall
health at birth. Babies born to women with high-risk pregnancies treated
with PROCHIEVE® 8%
(progesterone gel) appear to be less likely to need intensive care than
babies born to mothers treated with placebo, Columbia Laboratories, Inc.
(NASDAQ:CBRX) announced today. The data are published in the October
issue of Ultrasound in Obstetrics & Gynecology (also known as The
White Journal), the official publication of the International
Society of Ultrasound in Obstetrics and Gynecology.
Researchers conducted a secondary analysis of phase III data from the
largest-ever singleton preterm birth prevention study with progesterone
looking specifically at a group of 46 women with high-risk pregnancies
because they had a short cervix (less than 2.8 cm measured by
trans-vaginal ultrasound). This analysis shows several statistically
significant findings, including:
-
Only one out of six (16%) newborns of mothers treated with vaginal
progesterone gel needed to be admitted to neonatal intensive care
units compared to one out of two (52%) newborns of mothers treated
with placebo (p-value of 0.016); and
-
Infants born to mothers treated with vaginal progesterone gel who were
admitted to intensive care units spent on average only one day in
intensive care compared to more than two weeks for those babies of
mothers who received placebo (p-value of 0.013).
This is the first and only preterm birth prevention study that is
associated with statistically significant improvements in clinically
important measures of infant outcomes. Additional studies are being
planned to repeat this unique finding.
In addition, the analysis provided new insight into which women with
high-risk pregnancies respond to treatment with vaginal progesterone
gel. It showed that treatment with vaginal progesterone gel may reduce
early preterm birth among women with a short cervix.
“When looking at a sample of 46 women with a
short cervix of less than 2.8 cm, zero of those who were started on
vaginal progesterone gel between 18-to-22 weeks of gestational age
delivered prior to 32 weeks of gestation, while almost one in three
women (29.6 percent; p=0.014) with a shortened cervix given a placebo
delivered prior to 32 weeks of gestation,”
said Emily DeFranco, DO, primary author of the study and clinical fellow
of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, and
Center for Preterm Birth Research at Washington University School of
Medicine in St. Louis. “Additionally, the
number of admissions and days spent in the neonatal intensive care unit,
important measures of neonatal outcome, for babies whose moms were given
vaginal progesterone gel were significantly lower than for those whose
moms received placebo. We’re excited about
these promising clinical implications, especially if confirmed in a
larger study.”
“Publishing these findings is an important
step toward informing healthcare providers about the group of women who
may benefit from vaginal progesterone by reducing their chances for
having an early preterm birth,” said study
co-author John O’Brien, M.D., affiliated with
Central Baptist Hospital, Lexington, KY. “There
are currently no FDA-approved treatments available to help prevent
preterm birth, so this research, combined with future studies, may lead
to viable treatment options.”
The published subset of data is from a randomized, double-blind,
placebo-controlled study -- the largest study to date evaluating the
effect of progesterone on early preterm birth in singletons. The report
on these data, entitled “Vaginal
Progesterone Is Associated With a Decrease in Risk for Early Preterm
Birth and Improved Neonatal Outcome in Women with a Short Cervix,”
is available at http://www3.interscience.wiley.com/cgi-bin/jhome/99020267.
“Based on the statistically significant
findings in the secondary analysis, we are moving forward with a
follow-up study using PROCHIEVE 8%,” stated
Robert S. Mills, president and chief executive officer of Columbia
Laboratories. “It is estimated that of the
more than 4.1 million live births in the U.S. each year, up to 30
percent of pregnant mothers have a cervical length less than or equal to
3.0 centimeters in mid-pregnancy. This includes many women with
first-time pregnancies, the group that has the largest number of
premature babies each year. We look forward to publishing the results of
the next study.”
A normal pregnancy is about 40 weeks. Preterm birth before 37 weeks
gestation is a leading cause of infant and neonatal death, continues to
rise, and occurs in more than 12 percent of pregnancies in the United
States. The negative health effects of preterm birth go far beyond the
first days of life; preterm birth is associated with a high prevalence
of severe neurological deficits and developmental disabilities.
These negative health outcomes have economic implications, as well. A
2005 March of Dimes study found that employers pay nearly 15 times more
in direct healthcare coverage costs for babies born prematurely –
in their first year of life – than for full
term babies, with an average cost of $41,610 for a premature baby vs.
$2,830 for a healthy, full-term baby. In a separate analysis, the March
of Dimes estimates that in 2002, almost half of hospital charges for
premature infants, or about $7.4 billion, were billed to employers and
other private insurers. This estimate was derived using the Nationwide
Inpatient Sample from the Agency for Healthcare Research and Quality.
"Preterm birth has such a profound effect on both babies and their
families that any research that can help us understand how to prevent
preterm birth is a significant advance," said Susan Wysocki, RNC, NP,
FAANP, president and chief executive officer National Association of
Nurse Practitioners in Women's Health.
The overall Phase III study, “Progesterone
Vaginal Gel for the Reduction of Recurrent Preterm Birth: Primary
Results from a Randomized, Double-blind, Placebo-controlled Trial,”
did not show a beneficial effect of progesterone treatment on reducing
the frequency of preterm birth in a larger population of high-risk women
identified with “only”
a history of spontaneous preterm birth.
Progesterone is a natural hormone found in all women, though levels of
progesterone increase during pregnancy. Progesterone is also a
well-established hormonal supplement required for successful infertility
treatments.
About PROCHIEVE 8%
PROCHIEVE® 8% is
natural progesterone FDA-approved for progesterone supplementation or
replacement as part of Assisted Reproductive Technology (ART) treatment
for infertile women with progesterone deficiency. Several trials showing
these benefits have been published. PROCHIEVE 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.
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 U.S.-based international pharmaceutical
company dedicated to the development and commercialization of women’s
healthcare and endocrinology products that use 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 Assisted Reproductive Technology treatment
for infertile women with progesterone deficiency, and PROCHIEVE®
4% (progesterone gel) for the treatment of secondary amenorrhea. The
Company also markets STRIANT®
(testosterone buccal system) for the treatment of hypogonadism in men.
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, 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), PROCHIEVE®
4% (progesterone gel), and STRIANT®
(testosterone buccal tablet) in the U.S.; the timely and successful
development of new 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 planned Phase III study of PROCHIEVE®
8% in short cervix patients; 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.
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