MARIETTA, Ga., June 17 GA-Solvay-analysis
MARIETTA, Ga., June 17 /PRNewswire/ -- Solvay Pharmaceuticals, Inc.
announced today that a new analysis of pivotal study data conducted by the Los
Angeles Biomedical Research Institute at Harbor-UCLA Medical Center showed
that initial treatment response of hypogonadal men with AndroGel(R)
(testosterone gel) 1% CIII had similar effects on subjects, regardless of
weight and body mass index (BMI). These study results were presented today at
the 2008 Endocrine Society Annual Meeting (ENDO) in San Francisco.
"Multiple studies have shown that obese men are at an increased risk of
having low testosterone levels, so these new findings provide important
insight into optimal treatment regimens for hypogonadal men," said Dr.
Christina Wang, a study investigator at the Los Angeles Biomedical Research
Institute at Harbor-UCLA Medical Center. "However, despite the growing body
of evidence surrounding the benefits of testosterone therapy for those who are
hypogonadal, men are often unaware that the symptoms they are experiencing can
be attributed to low testosterone and, therefore, are left undiagnosed and
untreated."
The analysis presented is based on a new subset evaluation of a six-month
safety and efficacy study of AndroGel published in 2000, from which
researchers originally concluded that AndroGel was effective in restoring
testosterone levels and in some cases, superior to a transdermal testosterone
patch. In 2004, an additional follow-up, 36-month, open-label extension study
was published that showed that AndroGel was safe for men to use over the long
term.
Study Highlights
The study presented at ENDO examined the relationship between BMI and sex
hormones in hypogonadal men both before and after treatment with testosterone.
The study found:
-- Neither testosterone nor free testosterone is significantly related to
BMI either before or after testosterone treatment.
-- Testosterone treatment decreases SHBG more in lean men than in obese
men, suggesting that SHBG is more influenced by the serum E2 and
E2/testosterone ratio than testosterone levels.
-- Interactions of obesity, sex hormone-binding globulin (SHBG) and serum
testosterone in men with low testosterone are complex both at baseline
and after testosterone treatment.
"We are pleased that the AndroGel pivotal data continue to aid physicians
and researchers in helping to treat men suffering from the symptoms associated
with low testosterone, as we learn more everyday about the appropriate
treatments for this patient population," said Dr. Stephen Hill, president and
chief executive officer, Solvay Pharmaceuticals, Inc.
About Low Testosterone
It is estimated that hypogonadism, also known as low testosterone, affects
more than 13 million men in the United States age 45 and older. Because signs
and symptoms of low testosterone are subtle and often overlap with other
common medical conditions, low testosterone is frequently undiagnosed. Signs
and symptoms of low testosterone include low sex drive, erectile dysfunction,
fatigue, depressed mood, reduced muscle mass and strength, increased fat body
mass and decreased bone mineral density.
Men with chronic conditions, such as obesity, diabetes, high blood
pressure, high cholesterol and asthma/COPD, are also more likely to have low
testosterone compared to other men. Below normal levels of testosterone can
be confirmed by a blood test. Testosterone treatment is designed to elevate a
hypogonadal male's testosterone levels into the normal physiologic range,
which may alleviate symptoms related to low testosterone. As with any
medication, patients should work with their physician to weigh treatment
benefits and risks.
About AndroGel(R)
AndroGel, the first U.S. Food and Drug Administration (FDA)-approved
testosterone gel available in a non-aerosol, metered-dose pump, is a once-
daily, clear, odorless topical testosterone gel approved in 2000 for
replacement therapy in men ages 18 and older for conditions associated with a
deficiency or absence of endogenous testosterone. AndroGel is the most
prescribed form of testosterone therapy for adult males in the United States.
Pivotal data showed that AndroGel was effective in restoring testosterone
levels to normal and in some cases, superior to a transdermal testosterone
patch.
-- AndroGel was effective in improving sexual function, mood, and muscle
strength; increasing lean body mass; and decreasing body fat.
-- It was demonstrated that AndroGel was more effective than a
testosterone patch in increasing lean body mass and decreasing body
fat, and had comparable effects with other symptoms.
-- Because of minimal skin irritation, subjects using AndroGel also had
higher compliance rates.
-- In a 2004 open-label, follow-up extension study, AndroGel was shown to
be safe for men to use over the long term.
The AndroGel pump is designed to deliver 1.25 grams of testosterone gel
per pump depression, and it is also available in 2.5 and 5 gram packets. This
gives patients two convenient ways to use AndroGel and offers physicians added
flexibility to move, if necessary, from the starting dose of 5g per day to
7.5g or from 7.5g to 10g per day.
AndroGel must not be used if you have known or suspected prostate cancer
or breast cancer (a rare condition for men). AndroGel must not be used by
women who are pregnant, may become pregnant, or breastfeeding, as testosterone
may cause fetal harm. The major risks of AndroGel include prostate
enlargement, prostate cancer, and transfer of testosterone to others
(including women and children). Transference can occur when vigorous skin-to-
skin contact is made with the application site and can be minimized by washing
your hands after application and covering the application site with clothing.
The most common adverse events reported are skin irritation where gel is
applied, breast development or tenderness, acne, prostate enlargement, changes
in lab test results, and changes in urinary habits.
Remember, this information does not take the place of the advice you get
from your doctor or other health care professional. Always talk with your
doctor if you have questions about AndroGel.
Unimed Pharmaceuticals, LLC., a wholly owned subsidiary of Solvay
Pharmaceuticals, Inc., holds the exclusive rights to AndroGel in the United
States.
About Solvay Pharmaceuticals, Inc.
Solvay Pharmaceuticals, Inc., of Marietta, Georgia is the U.S. subsidiary
of Solvay Pharmaceuticals. For more information, visit
www.solvaypharmaceuticals-us.com.
Solvay Pharmaceuticals is a research driven group of companies that
constitute the global pharmaceutical business of the Solvay Group. The
company seeks to fulfill carefully selected, unmet medical needs in the
therapeutic areas of neuroscience, cardio-metabolic, influenza vaccines,
gastroenterology, and men's and women's health. Its 2007 sales were EUR 2.6
billion and it employs more than 9,000 people worldwide. For more information,
visit www.solvaypharmaceuticals.com.
SOLVAY is an international chemical and pharmaceutical Group with
headquarters in Brussels. It employs more than 28,000 people in 50 countries.
In 2007, its consolidated sales amounted to EUR 9.6 billion, generated by its
three sectors of activity: Chemicals, Plastics and Pharmaceuticals. Solvay
(NYSE Euronext: SOLB.BE - Bloomberg: SOLB.BB - Reuters: SOLBt.BR) is listed on
the NYSE Euronext stock exchange in Brussels. Details are available at
www.solvay.com.
SOURCE Solvay Pharmaceuticals, Inc.
