Wyeth Pharmaceuticals, a division of Wyeth, announced that the U.S. Food and Drug Administration (FDA) has approved the 0.3 mg and 0.45 mg dosage strengths of Premarin (conjugated estrogens tablets, USP) for the prevention of postmenopausal osteoporosis. This approval is based on data from a prospective clinical study that found these low doses of Premarin to be as effective as the current standard dose in preventing postmenopausal bone loss in women with menopausal symptoms.
With this most recent action, FDA has issued four separate approvals in recent months pertaining to new low dose strengths of Premarin and Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) -- Premarin 0.3 mg, Premarin 0.45 mg, Prempro 0.3 mg/1.5 mg, and Prempro 0.45 mg/1.5 mg. These new dosage strengths are all indicated for use by menopausal women for the treatment of moderate to severe hot flashes, moderate to severe vaginal dryness, and for the prevention of postmenopausal osteoporosis.
These approvals are consistent with the recommendation to prescribe low dose postmenopausal hormone therapy. Women should take the lowest effective dose of postmenopausal hormone therapy for the shortest duration consistent with treatment goals and risks for the individual woman. The FDA, other health experts, and Wyeth recommend that when used solely for the prevention of postmenopausal osteoporosis, hormone therapy should be considered only for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered.
Three of these low dose strengths are currently available: Premarin 0.3 mg, Premarin 0.45 mg, and Premrpo 0.45 mg/1.5 mg. The company expects that Prempro 0.3 mg/1.5 mg will be available by the end of 2003.
"With this approval, women and clinicians have two additional low dose estrogen options to better individualize effective treatment for menopausal symptom relief and concomitant bone protection," says Victoria Kusiak, Vice President Global Medical Affairs, and North American Medical Director, Wyeth Pharmaceuticals. Data supporting the efficacy of low doses of Premarin for the prevention of osteoporosis are based on a substudy of the Women's Health, Osteoporosis, Progestin, and Estrogen (HOPE) trial, a prospective, randomized, double-blind, placebo-controlled, multicenter study of 2,673 healthy postmenopausal women age 40 to 65 years. A total of 822 women participated in the bone substudy.
Postmenopausal estrogen therapy, which was first introduced more than 60 years ago, remains an important therapeutic option for menopausal women. Postmenopausal estrogen/hormone therapy is the only treatment approved by the FDA for the relief of menopausal symptoms and the concomitant prevention of postmenopausal osteoporosis.
Wyeth's hormone therapy products are prescribed more often than any other brand of postmenopausal hormone therapy.