Wyeth applies for approval of two women’s health drugs

Wyeth has submitted new drug applications (NDAs) for two drugs targeted at treating disorders associated with the menopause.

The first drug, bazedoxifene, is a selective oestrogen receptor modulator intended to prevent postmenopausal osteoporosis, a disease associated with reduction of oestrogen levels following the menopause.

Wyeth’s other drug, desvenlafaxine succinate, is a non-hormonal drug targeted at menopausal women suffering from moderate to severe vasomotor symptoms, such as night sweating or hot flushes.

Joseph Cambardo, senior vice-president of global medical affairs at Wyeth, remarked: “If approved, both bazedoxifene and desvenlafaxine succinate will give physicians additional options to help meet the individualised needs of their menopausal patients.

“The simultaneous submission of these two separate NDAs emphasizes Wyeth’s position as a leader and innovator in women’s health.”

“Wyeth continues to support clinical research and drug development with the goal of meeting the health care needs of women worldwide,” he concluded.

Bazedoxifene has been used in phase III trials and was found to improve bone health as well as vasomotor symptoms, without stimulating uterine or breast tissues.

Desvenlafaxine succinate has also been used in phase III studies in patients with major depressive disorder, where it demonstrated a “significantly improved” effect depressive symptoms patients in comparison to the placebo.

The UK’s National Osteoporosis Society says that women who have had an early menopause or hysterectomy are at greater risk of developing osteoporosis. One in two women over the age of 50 will break a bone largely as a result of the disease, according to the charity.

Low levels of testosterone in men can also increase the risk of developing the disease.

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