Pfizer and partner Ligand Pharmaceuticals have announced that the US Food and Drug Administration has accepted their file for their bazedoxifene/conjugated estrogens combination.
BZA/CE has been developed for non-hysterectomised women for the treatment of moderate-to-severe vasomotor symptoms and vulvar and vaginal atrophy associated with menopause, as well as the prevention of postmenopausal osteoporosis. The FDA has given the treatment a Prescription Drug User Fee Act date of October 3, 2013.
The New Drug Application is based on a Phase III programme, which included 7,500 postmenopausal women. The most common adverse drug reactions observed in the trials were abdominal pain, vaginal yeast infection and muscle spasms. The filing follows a similar submission to the European Medicines Agency earlier this year.
Gail Cawkwell, head of Pfizer’s medical affairs, said that "this milestone moves us one step closer towards potentially providing the first new treatment option in the USA in years for the treatment of these women’s menopausal symptoms".
On its own, bazedoxifene, a selective estrogen receptor modulator (SERM), is not approved in the USA but got the green light in Europe in April 2009 for postmenopausal osteoporosis.