The FDA has approved Pfizer’s Duavee 0.45mg/20mg tablets, a novel therapy for women with a uterus, for the treatment of moderate-to-severe vasomotor symptoms associated with menopause and for the prevention of postmenopausal osteoporosis. 

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Duavee is the first and only therapy to pair conjugated estrogens with the selective estrogen receptor modulator (SERM), bazedoxifene.

Bazedoxifene helps protect the uterine lining against hyperplasia that may result from estrogen-alone treatment. The combination of conjugated estrogens with bazedoxifene allows Duavee to work selectively in different tissues to activate estrogen receptors in some while inhibiting estrogen activity in others (the uterus).

The approval is based on Phase 3 clinical trials in the Selective Estrogens, Menopause, And Response to Therapy (SMART) program. These trials evaluated the safety and efficacy of Duavee in generally healthy, postmenopausal women with a uterus for the treatment of moderate-to-severe hot flashes, and the prevention of postmenopausal osteoporosis.

Results from one trial demonstrated that Duavee significantly reduced the number of moderate-to-severe hot flashes by 74% at 12 weeks, as compared with placebo (47%). This means that prior to starting treatment, women on Duavee had on average 10 hot flashes per day while women on placebo had 11. 

After 12 weeks of treatment, women taking Duavee experienced on average three hot flashes per day while women taking placebo had six. In addition, significant decreases in mean hot flash severity were seen at 12 weeks (39%), as compared with placebo (13%).

In other clinical trials, at years one and two, Duavee significantly increased bone mineral density in the total hip and lumbar spine from baseline compared with decreases seen with placebo.

The FDA has also issued a Complete Response Letter  regarding a 0.625mg/20mg dose of Duavee. This was the only dose submitted for a proposed additional indication for vulvar and vaginal atrophy.

Duavee 0.45mg/20mg tablets will be available  in the first quarter of 2014.

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