BETHESDA, MD 04 Oct 2013—Pfizer on October 3 announced the approval of Duavee, a conjugated estrogens– bazedoxifene combination product, for the treatment of moderate-to-severe vasomotor symptoms and the prevention of osteoporosis in postmenopausal women.
for Duavee includes a boxed warning, common to all drugs in the class, stating that estrogen therapy should not be used for the prevention of cardiovascular disease or dementia. The boxed warning also describes the increased risk for endometrial cancer, thromboembolic events, and dementia in postmenopausal women who use unopposed estrogens.
Because of the known risks associated with the use of unopposed estrogens, the estrogen component of Duavee is paired with bazedoxifene, a selective estrogen-receptor modulator that acts as an estrogen agonist in some estrogen-sensitive tissues and an antagonist in others.
The labeling for Duavee states that bazedoxifene reduces the risk of endometrial hyperplasia that can occur with the conjugated estrogens component.
Duavee is indicated for use only in women with an intact uterus. The product should be used for the shortest duration of time necessary to meet the patient's treatment goals.
When used solely for the prevention of osteoporosis, Duavee should be prescribed only for women at high risk for the condition, and the need for continued therapy should be reassessed periodically, according to the labeling. The labeling notes that women should ensure that they maintain an adequate daily intake of calcium and Vitamin D.
Duavee is contraindicated in women with undiagnosed abnormal uterine bleeding, a history or suspicion of breast cancer or estrogen-dependent neoplasia, active or past history of venous or arterial thromboembolism, or a history of hypersensitivity to any of the product's ingredients.
Each Duavee oral tablet contains 0.45 mg of conjugated estrogens and 20 mg of bazedoxifene. The recommended dosage of the product is one tablet taken daily with or without food. The tablets should be swallowed whole and not crushed or chewed.
In clinical trials, adverse events reported by at least 5% of women taking Duavee included muscle spasms, nausea, diarrhea, upset stomach, abdominal pain, throat pain, dizziness, and neck pain.
Duavee will be packaged in 30-tablet blister packs and should be dispensed in the original packaging. The product should be stored at room temperature and the blisters kept intact until use.
Pfizer expects Duavee to be available in the first quarter of 2014.