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| |  Testoderm Patch Now Available For Testosterone Deficiency PALO ALTO, CA, -- March 11, 1998 -- ALZA Corp. announced that Testoderm(R) TTS (Testosterone Transdermal System) CIII, a prescription product for replacement therapy in testosterone-deficient men, is now available in the United States. Testoderm TTS is a thin, clear patch that may be applied to the arm, back or upper buttocks. In clinical studies, daily application of Testoderm TTS maintained normal serum testosterone levels and was associated with a low incidence of skin irritation. The product, which is available in a 5 mg dose, was approved by the U.S. Food and Drug Administration in December 1997. "We are confident Testoderm TTS will be well received by patients and physicians alike, particularly given the product's low incidence of skin irritation," said Sam Saks, MD, ALZA's senior vice president of medical affairs. "In addition, the significant role of testosterone in men's health is gaining increased recognition in the medical community." While it has been well established in clinical research that testosterone influences sexual drive, energy levels and mood, studies are being conducted to investigate correlations between testosterone and bone mineral density, osteoporosis and other conditions. In a related news release issued today, the results of an ALZA-sponsored national survey indicated that most men are unaware of the key role testosterone plays in their health and have little knowledge about the symptoms of low testosterone. When asked to name symptoms typically associated with low testosterone, 68 percent could not name a single symptom. The most common symptom named was decreased sex drive, cited by only 15 percent of men. "These findings indicate that men's lack of knowledge may be one reason why this condition often goes untreated," said Laurence Katznelson, MD, an endocrinologist at Massachusetts General Hospital in Boston. "Because few men recognise symptoms associated with testosterone deficiency -- and even fewer recognise the significant impact testosterone has on their health -- a large number may be ignoring their symptoms." Symptoms of testosterone deficiency include decreased sex drive, erectile dysfunction (impotence), lethargy or low energy, fatigue, depressed mood, loss of facial/body hair and loss of lean muscle mass. Testosterone deficiency Testoderm TTS is a new patch designed to provide 24-hour delivery of testosterone for testosterone deficient men. In clinical studies, 94 percent of patients achieved serum testosterone levels within the normal range. Testoderm TTS features a proprietary adhesion technology that allows the patch to be removed before and reapplied after swimming, bathing or exercising. In addition, men using the product have the option to stay with a preferred application site each day (no site rotation is necessary) and may choose from a wide choice of application sites (arm, back or upper buttocks). In clinical trials, the most commonly reported adverse events were transient itching (12 percent), moderate or severe erythema (three percent) at the application site and headache (five percent). Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hyperplasia and prostatic carcinoma. As with all androgens, Testoderm TTS should not be used in men with carcinoma of the breast or known or suspected carcinoma of the prostate. The product must not be used in women. More information on: Alza Corp.
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