Hormone-Free Hot Flash Drug on Horizon
But Experimental Drug Pristiq Gets Mixed Reviews
May 9, 2007 (San Diego) -- An experimental treatment for menopause-related
hot flashes and night sweats that doesn’t use hormones generally works well,
The new medication, called Pristiq, is under review by the FDA, according to
the manufacturer, Wyeth Pharmaceuticals.
"Pristiq is going to fill a needed void," says David Archer, MD,
professor of obstetrics and gynecology at Eastern Virginia Medical School in
He's referring to the void left when legions of women gave up hormone
replacement therapy after a federally funded trial in 2002 showed that
long-term hormone therapy boosts risks of heart attack, breast cancer, and
other problems. Archer led clinical trials of Pristiq and has worked as a
consultant for Wyeth.
But another expert not involved in the research cautions that the studies
are preliminary and the exact role the new medication will have in relief of
menopausal symptoms is yet to be determined.
Researchers presented the studies at the 55th Annual Clinical Meeting of the
American College of Obstetricians and Gynecologists in San Diego.
Pristiq is a modified version of Wyeth's antidepressant Effexor, Archer
says. Effexor and Pristiq belong to a class of drugs known as
serotonin/norepinephrine reuptake inhibitors, or SNRIs.
When a woman is going through menopause, fluctuations in estrogen may
diminish both brain chemicals serotonin and norepinephrine, according to Wyeth.
Pristiq is thought to work by making more of both substances available,
improving mood and menopausal symptoms in the process.
In five studies presented Tuesday and Wednesday at the meeting, Pristiq was
evaluated for its value in relieving hot flashes and night sweats, reducing
nighttime awakenings from night sweats, and improving mood. Because sexual
problems have been associated with the use of some antidepressants, another
study looked at whether Pristiq affected women's sex lives.
The results were mixed:
Hot flashes. In a study of 541 women with 50 or more moderate
to severe hot flashes weekly, the 100-milligram dose of Pristiq reduced hot
flashes by nearly 60% at week 12, and the 150-milligram dose reduced them by
66%. In comparison, placebo reduced them by 47%, says Archer, an author of that
In a 12-month study of the drug, women who had 50 or more moderate to severe
hot flashes weekly were assigned to placebo or Pristiq (50, 100, 150, or 200
milligrams), says Margery Gass, MD, professor of obstetrics and gynecology at
the University of Cincinnati and an author of the study. She found a 60% to 64%
reduction in the hot flashes as well as fewer nighttime awakenings due to night
sweats. "Overall, the 100-milligram dose worked best," she tells
But in another study of 465 women, conducted by James Pickar, MD, of Wyeth,
Pristiq did not work much better than placebo and was inferior to
tibolone, a hot-flash-relieving drug not available in the U.S. At week 12,
placebo reduced hot flashes by 57.5%, Pristiq by 57.7%, and tibolone by