Pfizer’s menopause drug approved by US FDA

The US FDA has approved Pfizer's Duavee for the treatment of moderate-to-severe vasomotor symptoms associated with menopause and the prevention of postmenopausal osteoporosis.

Duavee (conjugated estrogens/ bazedoxifene) is the first and only therapy to pair conjugated estrogens with an estrogen agonist/antagonist, also known as a selective estrogen receptor modulator (SERM). DUAVEE uses bazedoxifene - instead of a progestin - to help protect the uterine lining against hyperplasia that may result from estrogen-alone treatment.

"We know that many women currently experiencing menopausal symptoms are not receiving treatment and have not talked to their doctor about hormone therapy. It is clear that the menopause dialogue needs to improve. The approval of DUAVEE, an important, novel and effective treatment, presents a new opportunity for women and their doctors to discuss appropriate options for managing hot flashes and preventing osteoporosis."

Gail Cawkwell, MD, PhD, Vice President, Pfizer Medical Affairs.

Pfizer anticipates that Duavee will be available in the US in the first quarter of 2014.

Approximately 33 million women in the United States between the ages of 45-59 are affected by menopause. Based on survey data, an estimated 50% of postmenopausal women experience moderate-to-severe vasomotor symptoms, commonly known as "hot flashes".