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FDA Accepts New Drug Application for Bazedoxifene/Conjugated Estrogens, Investigational Treatment for Menopause and Osteoporosis

Approval decision scheduled for October 2013 (Dec. 13)

The FDA has accepted for review a new drug application (NDA) for bazedoxifene/conjugated estrogens (BZA/CE, Pfizer/Ligand Pharmaceuticals), a potential new medicine for non-hysterectomized women for the treatment of moderate-to-severe vasomotor symptoms (VMS) and vulvar and vaginal atrophy (VVA) associated with menopause, as well as for the prevention of postmenopausal osteoporosis. The FDA Prescription Drug User Fee Act (PDUFA) date is October 3, 2013.

BZA/CE pairs the selective estrogen receptor modulator (SERM) bazedoxifene with conjugated estrogens. BZA/CE was studied in the SMART (Selective Estrogens, Menopause And Response to Therapy) phase III trials, which included approximately 7,500 postmenopausal women. The SMART trials assessed the safety and efficacy of BZA/CE for the treatment of moderate-to-severe VMS and VVA associated with menopause, as well as for the prevention of postmenopausal osteoporosis. The most common adverse drug reactions observed in these studies were abdominal pain, vaginal yeast infection, and muscle spasms.

Menopause is associated with reduced functioning of the ovaries due to aging, resulting in lower levels of estrogens and other hormones. It is estimated that approximately 43 million women in the U.S. are of menopausal age, i.e., between the ages of 40 and 59 years. Of these women, 17 million experience vasomotor symptoms, and 9 million experience moderate-to-severe symptoms. Most menopausal women experiencing moderate-to-severe vasomotor symptoms are not currently treating their symptoms.

Osteoporosis is a disease of the bones that leads to an increased risk of fracture. Decreased estrogen levels at the time of menopause are associated with rapid bone loss, making women more susceptible to osteoporosis. About 60% of women 50 years of age or older have low bone mass or osteoporosis.

Source: Ligand Pharmaceuticals; December 13, 2012.

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