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FDA Approves Menopause Drug Duavee (Conjugated Estrogens/Bazedoxifene)
Product will be available in early 2014 (October 3)
The FDA has approved Duavee (conjugated estrogens/bazedoxifene, Pfizer) 0.45 mg/20 mg tablets for the treatment of moderate-to-severe vasomotor symptoms associated with menopause and the prevention of postmenopausal osteoporosis in women with a uterus.
When prescribing solely for the prevention of postmenopausal osteoporosis, clinicians should consider therapy with Duavee only for women at significant risk, and non-estrogen medication should be carefully considered.
Duavee is a once-daily tablet taken orally. It is recommended that all menopausal hormone therapies, including Duavee, be used for the shortest duration consistent with treatment goals and risks for the individual woman. The drug is expected to be available in the U.S. in the first quarter of 2014.
Approximately 33 million women in the U.S. are between the ages of 45 and 59 years, and the average age of menopause in the U.S. is 51. Based on survey data, an estimated 50% of postmenopausal women experience moderate-to-severe vasomotor symptoms, commonly known as “hot flashes.”
Duavee is the first therapy to pair conjugated estrogens with an estrogen agonist/antagonist, also known as a selective estrogen receptor modulator (SERM). The treatment uses bazedoxifene instead of a progestin to help protect the uterine lining against hyperplasia that may result from estrogen monotherapy.
Source: Pfizer; October 3, 2013.