Pfizer Inc. PFE and Ligand Pharmaceuticals Incorporated LGND
today announced that the United States Food and Drug Administration (FDA)
accepted for review a New Drug Application (NDA) for bazedoxifene/conjugated
estrogens (BZA/CE), 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 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 has been studied in a Phase III clinical
development program (Selective estrogens, Menopause And Response to Therapy
[SMART] trials), which included approximately 7,500 postmenopausal women and
assessed the safety and efficacy of BZA/CE for the treatment of
moderate-to-severe VMS and VVA associated with menopause, as well as the
prevention of postmenopausal osteoporosis. The most common adverse drug
reactions observed in the SMART trials were abdominal pain, vaginal yeast
infection and muscle spasms.
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