New option for treating menopausal vasomotor symptoms receives FDA approval

A conjugated estrogen/bazedoxifene formulation (Duavee) was approved by the FDA in early October to treat moderate-to-severe menopausal vasomotor symptoms and prevent menopausal osteoporosis in women with an intact uterus.

“Endometrial safety studies up to 1 year in length suggest that the SERM (bazedoxifene) component of this combination formulation prevents the elevated risk of endometrial hyperplasia associated with estrogen-alone treatment,” said Andrew M. Kaunitz, MD.

“[The new drug] is an alternative to hormone therapy in women with a uterus who are experiencing bothersome vasomotor symptoms in menopause,” concluded JoAnn V. Pinkerton, MD, in a NAMS presentation entitled, “Beyond hormone therapy: Innovative options for treatment of hot flashes.” To hear Dr. Pinkerton describe how much relief from their symptoms (specifically hot flash frequency and severity) patients can expect, as well as advice on patient selection, click on the audio player below.

“In clinical trials, the most commonly reported side effects [of Duavee] included muscle spasms, nausea, diarrhea, upset stomach, abdominal pain, throat pain, dizziness, and neck pain,” Dr. Kaunitz reported.

The manufacturer’s (Pfizer) Web site indicates that Duavee will be available in the first quarter of 2014.