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. The patch will be available in pharmacies in January 2004.
"Climara Pro offers a significant change from the hormonal treatment options of the past," said Marie Foegh, M.D., D.Sc., Vice President of Clinical Development for Female Healthcare at Berlex. "This is the first hormone therapy in the U.S. with levonorgestrel, a progestin that has been used worldwide in women's health therapies for more than 20 years, with millions of patient-years of experience." Thousands of U.S. women each day reach menopause, many of them suffering from vasomotor symptoms that negatively impact their lives. FDA approval of a new, unique option lends credibility to the fact that hormone therapy remains an important and effective way to manage those often detrimental symptoms.
"Recent studies have underscored the importance of having new options for women during menopause, and it is critical for a woman to carefully review all of her options with her healthcare provider," said James A. Simon, M.D., Clinical Professor, George Washington University, specializing in menopause, infertility, reproductive endocrinology, osteoporosis and gynecology, and a Climara Pro investigator. "New low dose Climara Pro provides another important opportunity to individualize treatment for each woman."
Like Climara® (estradiol transdermal system), Berlex's once-a-week estrogen-only patch, Climara Pro delivers the hormones continuously and directly through the skin, 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, whereas Climara is appropriate for women who have had a hysterectomy.
Data Demonstrate Safety, Efficacy and Tolerability
Two well-controlled, randomized clinical trials showed that Climara Pro rapidly and effectively controlled menopausal symptoms. For many patients, the frequency and severity of hot flashes was significantly reduced as early as week one, and 90 percent of women experienced an 80 percent reduction in hot flash frequency by week 12.
As a transdermal patch, Climara Pro has a favorable side effect profile, with very low rates of nausea and gastrointestinal complaints that are commonly associated with oral hormonal treatments. Clinical trial participants using Climara Pro also reported a low skin irritation rate, no effect on body weight and a bleeding profile comparable to other hormone therapy. Trials also showed a high level of compliance and a low discontinuation rate due to application-site irritation.
Transdermal delivery avoids first-pass effects through the liver during absorption, which may help avoid drug-to-drug interactions with other products metabolized by the liver. In addition, transdermal hormone therapy, unlike oral therapy, does not increase triglycerides or sex hormone binding globulin (SHBG).
Estrogen/progestin combinations should not be used by women with known or suspected pregnancy, breast cancer, estrogen-dependent neoplasia, undiagnosed abnormal genital bleeding, active thrombophlebitis, thromboembolic disorders or stroke, liver dysfunction or disease, or any known hypersensitivity to estrogen, progestin or any Climara Pro transdermal system components. Estrogens with or without progestins should not be used to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase a woman's risk of heart attacks, strokes, breast cancer, and blood clots. A woman and her healthcare provider should discuss regularly whether she still needs estrogen treatment. In the absence of data on Climara Pro comparable in scope to that of the Women's Health Initiative (WHI), the risks identified in the WHI should be assumed to be similar for all postmenopausal hormone therapy.
Committed to developing novel diagnostics and therapeutics that address unmet medical needs, Berlex, Inc., a US affiliate of Schering AG, Germany (NYSE: SHR), develops and markets diagnostic imaging agents, treatments in the areas of female healthcare and dermatology, as well as specialized therapeutics for life-threatening and disabling diseases in the fields of the central nervous and cardiovascular systems, oncology, and gastroenterology. Berlex has business operations in New Jersey, California and Washington. For more information, please visit www.berlex.com.
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