ALZA’s TESTODERM TESTOSTERONE PATCH WILL BE AVAILABLE IN EARLY 1994:

ALZA's TESTODERM TESTOSTERONE PATCH WILL BE AVAILABLE IN EARLY 1994: approved Oct. 7, the Testoderm Testosterone Transdermal System is a transdermal scrotal patch that is indicated "for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone," including primary hypogonadism and hypogonadotropic hypogonadism, approved labeling states. Alza filed the NDA for Testoderm (19-762) on July 31, 1987. FDA classified Testoderm as a "6S" drug, designating a new claim for an already marketed product given standard review by the agency. Testoderm is classified by the Drug Enforcement Administration as a Schedule III controlled substance. Alza is forming a small sales force to market Testoderm. Initially, the sales force will detail the product to endocrinologists and urologists. One estimate puts the incidence of hypogonadism at up to 5% of the male population between the ages of 20 and 65. In two 12-week clinical studies, Testoderm therapy was studied in 72 hypogonadal men, of whom 45 showed "statistically significant increases in sexual activity," with increases in mean sexual events per week, including sexual intercourse, orgasm, waking erections and spontaneous erections, labeling states. Use of Testoderm also produced "positive effects on mood and behavior," labeling notes. Labeling states that "normal levels of testosterone have been maintained in patients who have worn the systems for up to six years." In a study of 30 patients, 60% "achieved individual maximal testosterone concentrations greater than 500 ng/dL." Clinicals also showed decreases over three months in the high- density lipoprotein cholesterol levels of trial participants. HDL decreased 13% in that period while total cholesterol went down 8%. Over two years, decreases in total cholesterol were also reported, labeling notes. Testoderm is available in two patch sizes, delivering 4 mg/day and 6 mg/day of testosterone transdermally through the scrotum. The patch is worn for 22-24 hours per day. The most common side effects reported by the 104 patients treated in clinical trials were localized. "In U.S. clinical trials, most of the 72 patients filling out a daily questionnaire reported scrotal itching, discomfort or irritation at some time during therapy," labeling states. Adverse effects reported in five or fewer of the 104 patients included: gynecomastia, acne, prostatitis/urinary tract infection, breast tenderness and stroke, labeling states. FDA's revised approval letter dated Oct. 12 reminds Alza that is has committed to performing Phase IV studies on Testoderm following 80 patients for three to five years. Additionally, Alza has committed to perform lipid profiles on 20 patients who will be given testosterone enanthate injections for six weeks, washed out and then placed on Testoderm therapy for three to five years. The approval letter notes further that, based on the data submitted, Testoderm's expiration date will be 24 months, with an extension possible "when additional "real time" data is submitted for the systems" manufactured at Alza's Vacaville, Calif facility. The agency also suggested that each carton label contain a statement about whether each unit-dose package in the carton is "child resistant."