PEAPACK, N.J -- Pharmacia Corporation (NYSE: PHA) today announced that the U.S. Food and Drug Administration (FDA) has approved ACTIVELLA(TM), (estradiol/norethindrone acetate tablets) for the prevention of osteoporosis associated with menopause.

Osteoporosis is a condition marked by a decrease in bone mineral density (BMD), which causes bones to become fragile, increasing the risk of fractures.

The osteoporosis indication was approved based on the results of two randomized, placebo controlled, two-year clinical trials involving 462 postmenopausal women in the U.S. and Europe. The studies found Activella to be effective in preventing bone loss in postmenopausal women compared to the placebo group, based on measurement of various skeletal sites, including the lumbar spine and total hip.

Activella is a continuous-combined once daily tablet combining estrogen (1 mg estradiol) and progestin (0.5 mg norethindrone acetate). It was previously approved by the FDA for the treatment of moderate to severe vasomotor symptoms associated with menopause and for vulvar and vaginal atrophy associated with menopause. Use of the product is restricted to women with an intact uterus.

A debilitating and sometimes life-threatening disease, osteoporosis -- or porous bone -- is a major public health threat for more than 28 million Americans -- 80 percent comprised of women. It is characterized by low bone mass and structural deterioration of bone tissue, leading to bone fragility and an increased susceptibility to fractures of the hip, spine and wrist. At menopause, a woman experiences bone loss, which increases her risk for bone fractures. Bone fractures are a major cause of morbidity and mortality associated with osteoporosis.

In January of 2000, Pharmacia acquired the U.S. rights to Activella from Novo Nordisk A/S. Under terms of the agreement, Pharmacia also acquired the rights to Vagifem(R) (estradiol vaginal tablet, USP), approved in the U.S. for the treatment of atrophic vaginitis resulting from estrogen deficiency; and Innofem(TM) (estradiol tablet, USP), an estrogen-only product approved in the U.S. for a variety of indications associated with hormone treatment and estrogen replacement.

Estrogen replacement therapy (ERT) and HRT are not suitable for everyone, including women with known or suspected pregnancy, breast cancer, estrogen-dependent neoplasia, active deep vein thrombosis, thromboembolic disorders or stroke, undiagnosed genital bleeding or liver dysfunction or disease. Anyone who has hypersensitivity to any of the components of Activella should not take it. Common side effects may include breast tenderness/pain, upper respiratory complaints, headache and postmenopausal bleeding.

Activella will be available in pharmacies by summer 2000.

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