Alza Corp.'s transdermal testosterone product, Testoderm, wasapproved by FDA on Oct. 7, the company announced onMonday.

The product will be launched in early to mid-1994 at a priceyet to be disclosed.

This is the sixth transdermal product to be developed by Alzaand the first the company will market itself. Alza (ASE:AZA) ofPalo Alto, Calif., said it will hire a small sales force to marketTestoderm.

Approved labeling states that the testosterone product isindicated for hormonal replacement therapy in males forconditions associated with a deficiency or absence ofendogenous testosterone.

According to the product label, "after at least three weeks ofTestoderm therapy when steady state is obtained, 30hypogonadal men treated with 6 mg/d systems for 22 hoursdaily achieved mean maximum serum testosteroneconcentrations of 593 ng/dL at two to four hours postapplication. Sixty percent of the patients achieved individualmaximal testosterone concentrations (greater than) 500 ng/dL."

It also noted that "normal levels of testosterone have beenmaintained in patients who have worn the systems for up tosix years."

The product is contraindicated in men with carcinoma of thebreast or known or suspected carcinoma of the prostate.

TheraTech Inc. is also developing a transdermal testosteronepatch that may be applied to any part of the body. Alza's patchis to be applied only to the scrotum. Testoderm labeling statesthat "scrotal skin is at least five times more permeable totestosterone than other skin sites. The Testoderm system willnot produce adequate serum testosterone concentration if it isapplied to non-genital skin." Currently, testosterone isadministered intravenously every three weeks.

Other transdermal products developed by Alza includeTransderm Scop (scopolomine) for prevention of motionsickness; Transderm-Nitro (nitroglycerin) for prevention andtreatment of angina; Estraderm (estradiol) for treatment ofpost-menopausal symptoms; Catapres-TTS (clonidine) fortreatment of hypertension; Duragesic (fentanyl) formanagement of chronic pain in patients requiring opioidanalgesia; and Nicoderm (nicotine) for smoking cessation. Ciba-Geigy markets the first three products, Boehringer IngelheimPharmaceuticals Inc. markets Catapres-TTS, JanssenPharmaceutical markets Duragesic, and Marion Merrell Dowmarkets Nicoderm.

-- Brenda Sandburg News Editor

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