Pfizer has secured approval from the US Food and Drug Administration (FDA) for its new drug Duavee (conjugated estrogens/bazedoxifene) 0.45mg/20mg tablets, for treatment of hot flashes in women with menopause.
Duavee is intended for the treatment of moderate-to-severe vasomotor symptoms related with menopause and the prevention of postmenopausal osteoporosis in women.
According to the company, the drug is the first product that combines conjugated estrogens with a selective estrogen receptor modulator (SERM) like bazedoxifene.
This pairing with an estrogen agonist/antagonist enables Duavee to offer estrogen efficacy in treating moderate-to-severe hot flashes and preventing postmenopausal osteoporosis, while providing an alternative way to help protect the uterine lining from hyperplasia.
Duavee is a once daily tablet taken orally and is recommended as all other menopausal hormone therapies to be used for the shortest duration consistent with treatment goals and risks for the individual woman.
Pfizer Medical Affairs vice-president Gail Cawkwell said many women currently experiencing menopausal symptoms are not receiving treatment and have not talked to their doctor about hormone therapy.
"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," Cawkwell said.
The drug should not be used by women who have or had blood clots, have unusual vaginal bleeding, have or had certain cancers such as uterine or breast, liver problems, or bleeding disorders. In addition, the drug should not be used by those that are pregnant or may become so, or women who are breastfeeding.
Wyeth Pharmaceuticals, a subsidiary of Pfizer, is developing Duavee and is part of broader research collaboration with Ligand Pharmaceuticals.
The FDA has also issued a complete response letter for a 0.625mg/20mg dose of Duavee, which was the only dose submitted for a proposed additional indication for vulvar and vaginal atrophy.
FDA clearance is the first approval for Duavee in any country worldwide and the drug will likely be available in the US in the first quarter of 2014.
The approval is based on Phase III clinical trials in the selective estrogens, menopause, and response to therapy (SMART) programme, which assessed the safety and efficacy of the drug.
Results from the trial showed that the drug reduced the number of moderate-to-severe hot flashes by 74% at 12 weeks compared with placebo of 47%.
In addition, Duavee substantially increased bone mineral density in the total hip and lumbar spine from baseline compared with decreases seen with placebo, at years one and two, in other clinical studies.
Image: Pfizer subsidiary Wyeth Pharmaceuticals is developing hot flashes drug Duavee and is part of broader research collaboration with Ligand Pharmaceuticals. Photo: courtesy of NorbertNagel.
