MEAD JOHNSON’s ESTRACE ADDS POSTMENOPAUSAL OSTEOPOROSIS INDICATION

MEAD JOHNSON's ESTRACE ADDS POSTMENOPAUSAL OSTEOPOROSIS INDICATION at a starting dose of .5 mg daily for three weeks followed by a one-week period off the drug. FDA cleared the supplemental NDA for 17-beta-estradiol on Sept. 8, about six-and- a-half years after the initial filing of the application. Estrace was originally approved in mid-1975 for treatment of vasomotor symptoms associated with menopause. Estrace is not currently available in .5 mg individual tabs; the product is supplied as 1 mg and 2 mg scored tablets. The osteoporosis dosing information notes that Estrace dosages "may be adjusted if necessary to control concurrent menopausal symptoms." FDA approved labeling does not refer directly to clinical results from use of Estrace for osteoporosis. The company's introductory promotional material for the drug, however, cites two 18-month clinical studies involving 51 women. The studies were conducted at the Kaiser Permanente Medical Care Program in Oakland, and The University of California-San Francisco. Estrace therapy showed an increase of bone mass in postmenopausal women compared to placebo recipients. Patients given 2 mg of Estrace had a 2.5% increase in bone mass and those given 1 mg showed a 1.8% increase. Patients receiving .5 mg (the approved dosage) had bone mass increases of .3%. By comparison, women taking placebo recorded a 4.9% bone mass decrease. All patients in the studies, including placebo recipients, were also taking calcium supplements. Mead Johnson Labs notes that Estrace is the only oral estrogen replacement therapy that contains only 17-beta-estradiol. Synthetically produced, Estrace is chemically identical to the primary estrogen that is produced naturally by human ovaries, the firm says.