Unimed Pharmaceuticals, Inc. Reports AndroGel® Long-term Safety and Benefits
Improvements in mood, sexual performance, lean body mass and bone mineral density sustained in longest testosterone gel study
MARIETTA, Ga., May 4, 2004 – Unimed Pharmaceuticals, Inc., a wholly owned subsidiary of Solvay Pharmaceuticals, Inc., today reported that a three-year research study showed AndroGel® (testosterone gel) 1% CIII is safe and effective for men with hypogonadism, or low testosterone. Results of the 3-year study, the longest testosterone gel study to date, were published in the May issue of the Journal of Clinical Endocrinology & Metabolism.
AndroGel® is the first testosterone gel to be approved by the FDA. It is also the number one prescribed form of testosterone replacement therapy in the United States.
“We are pleased that clinical evidence continues to demonstrate the long-term benefits of treatment with AndroGel®,” said Harold H. Shlevin, Ph.D., president and CEO of Solvay Pharmaceuticals, Inc. and CEO and Chairman of the Board of Unimed Pharmaceuticals. “Solvay Pharmaceuticals is committed to monitoring the safety and efficacy of AndroGel® and we support additional long-term study of testosterone replacement therapy.”
The study was led by investigators at the Research and Education Institute (REI) at Harbor-UCLA Medical Center and conducted at multiple research centers across the U.S. Researchers studied 163 hypogonadal men between the ages of 19 and 68 (mean age = 51) who elected to receive continuous treatment with AndroGel® for up to 42 months. Patients were treated with AndroGel® at 5, 7.5 or 10 g per day.
Study authors reported significant and sustained improvements in mood and sexual performance as well as increases in lean body mass and bone mineral density. These improvements were maintained throughout treatment. Lean body mass increased (P = 0.0001, average of about 3 kg or 6.6 pounds) as early as three months after beginning treatment and was sustained with continuous treatment. An increase in muscle strength associated with the increase in lean mass also was reported, but did not reach statistical significance over time. Bone mineral density (BMD) increased (P=0.0001) by 0.76, 1.47 and 1.60 percent at the hip and 0.99, 3.10 and 3.80 percent at the spine after 6, 18 and 30 months of treatment. Hematocrit and hemoglobin levels increased as anticipated with androgen replacement. Prostate disorders were seen in six patients and skin irritability was reported as minimal and caused discontinuation in only one patient.
AndroGel® is a once-daily, clear, topical testosterone gel approved by the U.S. Food and Drug Administration in 2000 for the treatment of conditions associated with hypogonadism, or low testosterone, in men. AndroGel® is available in 2.5g and 5g sachets. Four to five million American men are estimated to suffer from low testosterone, the symptoms of which may include, diminished interest in sex, erectile dysfunction (ED), reduced lean body mass, decreased bone density, depressed mood and fatigue.
Androgens are contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate. AndroGel® is not indicated for use in women, has not been evaluated in women, and must not be used in women. Geriatric patients treated with androgens may be at an increased risk for the development of enlarged prostate and prostate cancer. Please refer to the AndroGel® prescribing information for complete safety information.
Solvay Pharmaceuticals, Inc. of Marietta, Georgia, is a research-based pharmaceuticals company, active in the therapeutic areas of cardiology, gastroenterology, mental health, women's health and a select group of specialized markets. It is a member of the worldwide Solvay S.A. chemical and pharmaceutical group, headquartered in Brussels, Belgium.
