FDA Approves AndroGel, First Gel to Treat Male Testosterone Deficiency
BUFFALO GROVE, Ill. (February 29, 2000) - Unimed Pharmaceuticals, Inc. today announced that AndroGel™ 1% (testosterone gel) (C-III) was approved by the U.S. Food and Drug Administration (FDA). The approval makes AndroGel™ the first-ever testosterone replacement gel to be approved by the FDA for replacement therapy in men for conditions associated with low testosterone. Low testosterone, also known as hypogonadism, affects approximately four to five million American men. The condition is linked with diminished interest in sex, impotence, reduced lean body mass, decreased bone density and lowered mood and energy levels. AndroGel™ will be available with a prescription in pharmacies throughout the United States by mid-summer. Unimed Pharmaceuticals, Inc. is a wholly owned subsidiary of Solvay Pharmaceuticals, Inc.
"We believe that doctors and men who are waiting for a more convenient testosterone treatment will regard AndroGel™ as a very attractive alternative to existing testosterone replacement therapy." said Robert E. Dudley, president and CEO, Unimed Pharmaceuticals, Inc. "AndroGel™ provides an easy, effective, invisible alternative to painful deep muscle injections and potentially irritating patches."
AndroGel™ is a unique, clear, colorless topical gel that men apply once daily to the shoulders, upper arms and/or abdomen. Upon application, AndroGel™ dries within a few minutes, during which time the skin absorbs the testosterone. The skin serves as a reservoir for the hormone, which slowly enters the bloodstream. Normal testosterone levels are restored soon after application. AndroGel™is the only FDA approved testosterone replacement therapy available in gel form. AndroGel™ provides men with a safe, effective and easy-to-use treatment that can be applied at home.
Clinical data from a U.S. phase III study conducted in men with hypogonadism indicated that AndroGel™ quickly raised circulating testosterone to desirable levels, and maintained it within normal range. The study also found that AndroGel™ increased sex drive, bone mineral density, and lean body mass and improved mood and energy levels.
"Research supporting the use of AndroGel™ is extremely solid and the unique gel delivery method is very versatile," said Ronald S. Swerdloff, M.D., Chief and Professor of Medicine, Division of Endocrinology at Harbor-UCLA Medical Center. "Testosterone deficient men who use AndroGel™ can experience physical and psychological benefits with this convenient, well-tolerated gel."
Safety data from clinical studies of AndroGel™ demonstrate it to be well tolerated. Androgens are contraindicated in men with carcinoma of the breast, or known or suspected carcinoma of the prostate. Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hyperplasia and prostatic carcinoma. AndroGel™ is not indicated for use in women and has not been evaluated in women. Pregnant women should avoid skin contact with AndroGel™ application sites in men. Testosterone may cause fetal harm.
Studies have shown that during vigorous skin to skin contact some of the testosterone in AndroGel™ can be transferred to the untreated individual. Residual testosterone on the skin can be removed with soap and water. Testosterone should not be used to improve athletic performance.
For full prescribing information, physicians and patients may visit www.Unimed.com or call 1-877-463-7645.
Unimed Pharmaceuticals, Inc., a wholly owned subsidiary of Solvay Pharmaceuticals, Inc., focuses on drugs with multiple indications in the therapeutic areas of hypertension, endocrinology, urology, HIV and other infectious diseases.
Unimed currently markets TevetenÒ (eprosartan mesylate) for the treatment of hypertension, Marinol (dronabinol) as an appetite stimulant for people living with HIV disease and as an antiemetic for people with cancer, AnadrolÒ-50 (oxymetholone) for the treatment of various anemias, and MaxaquinÒ (lomefloxacin HCl), a broad-spectrum quinolone antibiotic, for both complicated and uncomplicated urinary tract infections.
Solvay Pharmaceuticals, Inc. of Marietta, Georgia, is a research-based pharmaceuticals company, active in the therapeutic areas of cardiology, gastroenterology, mental health and women's health. It is a member of the worldwide Solvay Group of chemical and pharmaceutical companies, headquartered in Brussels, Belgium.
For more information contact:
Marissa Weber
Edelman Worldwide
(312) 240-2841
marissa_weber@edelman.co
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Shelly Wilt
Edelman Worldwide
(312)240-2839
shelly_wilt@edelman.com
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