Pfizer: Pristiq reduces hot flashes among postmenopausal women

WASHINGTON — A major depressive disorder treatment made by Pfizer significantly reduced the number and severity of moderate-to-severe hot flashes in postmenopausal women, compared with placebo, according to a new study.

The efficacy sub-study of 365 patients, conducted over a 12-week period, was part of a year-long, double-blind, placebo-controlled safety trial conducted in the United States and Canada for Pristiq (desvenlafaxine). Patients enrolled in the efficacy sub-study were required to have at least seven bothersome moderate-to-severe hot flashes per day, or 50 bothersome moderate-to-severe hot flashes per week at baseline.

Researchers found that by the fourth week, women treated with Pristiq experienced a 55% reduction in hot flash frequency (average decrease of 6.5 hot flashes per day from a baseline mean of approximately 12 hot flashes per day), compared with a 31% reduction in hot flash frequency (average decrease of 3.6 hot flashes per day from a baseline mean of approximately 12 hot flashes per day) in the placebo group.

At week 12, women in the Pristiq-treated group experienced a 62% reduction in hot flash frequency (average decrease of 7.3 hot flashes per day from a baseline mean of approximately 12 hot flashes per day), compared with a 38% reduction in hot flash frequency (average decrease of 4.5 hot flashes per day from a baseline mean of approximately 12 hot flashes per day) in the placebo group.

The data were presented at the 59th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in Washington, D.C.

Pristiq currently is under review by the Food and Drug Administration to expand its use as a treatment for moderate-to-severe vasomotor symptoms (i.e., hot flashes and night sweats) associated with menopause, Pfizer said.

“Pfizer is committed to women’s health and understands the impact that hot flashes and night sweats related to menopause can have on a woman’s life, and the importance of having options to treat menopausal symptoms,” said Steven Romano, Pfizer SVP and head of medicines development group for the primary care business unit. “If approved by the FDA for this indication, Pristiq will expand the range of effective treatment options available to help manage VMS in the United States.”