FDA Okays Duavee for Hot Flashes, Osteoporosis

Disclosures

October 03, 2013

The US Food and Drug Administration (FDA) today approved a novel estrogen-based drug for women to treat moderate-to-severe vasomotor symptoms associated with menopause as well as prevent postmenopausal osteoporosis, the agency said today.

The new drug for menopausal women (Duavee, Wyeth Pharmaceuticals, a division of Pfizer) is the first to combine conjugated estrogens with bazedoxifene, an estrogen agonist/antagonist. Bazedoxifene reduces the risk for endometrial hyperplasia, a possible precursor to cancer associated with the drug's estrogen component.

The combination of conjugated estrogens and bazedoxifene is indicated only for postmenopausal women who still have a uterus, according to the FDA.

In a news release today, Pfizer noted that drug makers producing estrogen products to manage postmenopausal symptoms in women with a uterus have traditionally added a progestin to lower the risk for hyperplasia. Bazedoxifene is a substitute for progestin in the drug approved today.

The FDA advises clinicians to prescribe the new drug "for the shortest duration consistent with treatment goals and risks" as they would any other estrogen-containing product. They also can prescribe the combination drug just to prevent osteoporosis. However, this indication is only for women who are at a significant risk of losing bone mass and strength, and clinicians must first consider alternatives that do not contain estrogen.

Muscle spasms, nausea, diarrhea, dyspepsia, upper abdominal pain, oropharyngeal pain, dizziness and neck pain were the most common adverse events observed in patients during clinical trials. The drug, a once-a-day tablet, will come with the same boxed warning as well as other warnings and precautions that appear on the labels of previously approved estrogen products.

Pfizer said that the estrogens/bazedoxifene drug will be available in the United States, the first country to approve it, in the first quarter of 2014.

The approval comes on the third day of a partial government shutdown, which stems from a Congressional stalemate over appropriating money for the fiscal year that began on Tuesday. Although 45% of its workers were set to be furloughed, and most of its work in food safety, nutrition, and cosmetics is curtailed, the FDA continues to approve new drugs. That activity is funded by manufacturers' "user fees" as opposed to Congressional appropriations.

More information on today's announcement is available on the FDA Web site.

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