The first new drug application is for the approval of bazedoxifene, a selective estrogen receptor modulator (SERM) investigated for the prevention of postmenopausal osteoporosis. During menopause women begin losing bone mass more rapidly, making them increasingly susceptible to osteoporosis.
The second is for desvenlafaxine succinate, a non-hormonal agent studied for the treatment of moderate to severe vasomotor symptoms associated with menopause, such as hot flashes and night sweats.
According to the North American Menopause Society, there are approximately 40 million women in the US of menopausal age and as many as 93% of women going through menopause experience vasomotor symptoms such as hot flashes.
“If approved, both bazedoxifene and desvenlafaxine succinate will give physicians additional options to help meet the individualized needs of their menopausal patients,” said Dr Joseph Camardo, senior vice president, Global Medical Affairs, Wyeth Pharmaceuticals.