FDA Menopause Drug Approval: Duavee to Combat Hot Flashes, Osteoporosis

By Daniel Distant, Christian Post Reporter Tuesday, October 08, 2013

An FDA menopause drug approval could help older women with hot flashes in the future. The latest drug, Duavee, was approved for treatment in women Thursday.

The FDA menopause drug approval would treat women with moderate to severe symptoms stemming from menopause, like hot flashes and osteoporosis. Duavee would be taken once a day, but is only recommended for women who have already considered non-estrogen medication, according to HealthDay News.

The FDA's approval was based on testing of Duavee- conjugated estrogens/bazedoxifene- in phase 3 clinical trials. 74 percent of women who took the pill had less hot flashes after three months of doses, while only 47 percent of women who took the placebo had reduced hot flashes, Pfizer said in a press release.

Also, trial results revealed that women who took Duavee had higher bone mineral density in the hip and lumbar spine after one to two years of doses, which could help them fight osteoporosis. Women who took the placebo had lower levels of bone density.

There are risks with taking Duavee, however. Muscle spasms, nausea, diarrhea, upset stomach, abdominal pain, throat pain, dizziness and neck pain are all common side effects of the drug. In addition, women who have had unusual vaginal bleeding, have had uterine or breast cancer, liver issues, are pregnant or may become pregnant are advised not to take the drug.

Pfizer teamed up with Ligand Pharmaceuticals, Inc. to develop Duavee. The main component, selective estrogen modulators, comes from the urine of pregnant horses.

Despite the risks, there is the potential for Duavee to become popular. There are over 37 million women close to or at the age of menopause, according to statistics from the Center for Disease Control and Prevention. Most women reach menopause between the ages of 40 and 59.