EU approves Duavive for Oestrogen Deficiency-Pfizer

Pfizer has received EU marketing authorization for Duavive (conjugated estrogens/bazedoxifene (BZA/CE)) from the European Commission where it is indicated for the treatment of Oestrogen Deficiency symptoms in postmenopausal women with a uterus (with at least 12 months since the last menses) for whom treatment with progestin-containing therapy is not appropriate.

Duavive was 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 Duavive for the treatment of estrogen deficiency symptoms, such as moderate-to-severe hot flashes. The most common adverse drug reactions observed in the SMART trials were abdominal pain, vaginal yeast infection and muscle spasms.