FDA approves Duavee for treatment of menopausal symptoms, prevention of osteoporosis

Pfizer announced that the FDA has approved its new treatment for moderate-to-severe vasomotor symptoms associated with menopause and prevention of postmenopausal osteoporosis in women with a uterus, according to a press release.

The novel therapy (Duavee), which combines conjugated estrogens with the selective estrogen receptor modulator bazedoxifene, is a once-daily 0.45-mg/20-mg tablet designed to be taken orally. According to the release, when used solely for the prevention of osteoporosis, the treatment should only be considered for women at significant risk for the condition.

The drug should not be used in women who have or had blood clots; are allergic to any of the ingredients; have unusual vaginal bleeding; have or had certain cancers, liver problems or bleeding disorders; or are pregnant, may become pregnant or are breast-feeding.

The agency based its approval on the phase 3 clinical trials in the Selective Estrogens, Menopause, and Response to Therapy (SMART) program evaluating the safety and efficacy of the drug in healthy, postmenopausal women with a uterus for the approved indications. In one trial, the number of moderate-to-severe hot flashes was reduced by 74% after 12 weeks of treatment vs. 47% with placebo. Data from other trials also demonstrated a significant increase from baseline in bone mineral density in the total hip and lumbar spine.

The manufacturer anticipates that the treatment will be available in the US in the first quarter of 2014, according to the release.