Testoderm Patch Cleared In U.S. For Testosterone Deficiency

PALO ALTO, CA -- December 19, 1997 – The United States Food and Drug Administration (FDA) has granted marketing clearance to Alza Corp.’s Testoderm® TTS (Testosterone Transdermal System) CIII for men with testosterone deficiency. Alza expects to introduce the product in the U.S. in early 1998.

Testoderm TTS is a thin, clear patch that can be placed on the arm, back or upper buttocks and delivers a 5 mg dose of testosterone through the skin over a 24-hour period.

In clinical studies, daily application of Testoderm TTS maintained normal serum testosterone levels, with delivery paralleling the normal circadian pattern of testosterone secretion and was associated with a low incidence of skin irritation. In the 457 men wearing Testoderm TTS for up to six weeks, the most commonly reported adverse events were application site reactions of transient itching (12 percent) and moderate or severe redness (three percent).

Testoderm TTS features a proprietary adhesion technology that allows the patch to be removed before and reapplied after such activities as swimming, bathing or exercising. In addition, men using Testoderm TTS have the freedom to stay with a preferred application site each day (no application site rotation is necessary).

While testosterone deficiency, or hypogonadism, affects an estimated one million men in the U.S., only 100,000 to 150,000 men are currently receiving testosterone replacement therapy. The most frequent causes of testosterone deficiency include tumors and other disorders of the testicles, pituitary gland or hypothalamus and Klinefelter's Syndrome.

Symptoms of testosterone deficiency include decreased energy, depressed mood and decreased libido. Transdermal testosterone replacement therapy is designed to restore normal testosterone levels and to alleviate these symptoms.

Testoderm TTS must not be used by men with a history of breast or prostate cancer and must not be used in women. Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hyperplasia and prostatic carcinoma.