Schering AG, Germany announced that the US Food and Drug Administration (FDA) has granted marketing approval for Climara Pro (estradiol/levonorgestrel transdermal system) for the treatment of menopausal symptoms. Climara Pro, a thin, translucent patch, is the first once-a-week combined hormone therapy approved in the US It will be marketed by Schering's US subsidiary, Berlex, Inc. which plans to launch Climara Pro in January 2004.
"Climara Pro will provide women with low doses of two well-accepted hormones," said Dr Philip Smits, head of Schering AG's gynecology & andrology. "Hormone treatment is one of the most effective ways to alleviate menopausal symptoms. Schering is committed to providing the best care in this field."
Transdermal (patch) technology allows for continuous delivery of hormones at doses much lower than in pills. Climara Pro delivers 0.015 mg per day of levonorgestrel and 0.045 mg per day of estradiol. Estradiol is the most active estrogen made by the ovary. This therapy is approved for the relief of moderate to severe vasomotor symptoms associated with menopause, such as hot flashes and night sweats.
Climara Pro is a transdermal hormone therapy (HT) with levonorgestrel, a progestin that has been used worldwide in a variety of women's healthcare products for more than 20 years with millions of patient-years of experience. This patch also contains estradiol, an estrogen that is identical to the estrogen a woman's body produces before menopause. Easily affixed to the skin, Climara Pro delivers 0.015 mg per day of levonorgestrel and 0.045 mg per day of estradiol transdermally, allowing for continuous delivery of hormones at doses much lower than in pills.
Like Climara (transdermal estradiol system), Schering's once-a-week estrogen-only patch, Climara Pro delivers hormones continuously and directly, with the benefits of unique 3M Drug Delivery Systems technology. With the addition of levonorgestrel, Climara Pro is indicated for use by women with an intact uterus, wheras Climara is appropriate for women who have had a hysterectomy.