The U.S. Food and Drug Administration has just approved the drug “Brisdelle” (paroxetine) for the treatment of hot flashes due to menopause.
This is the first non-hormonal treatment to be approved by the FDA for hot flashes associated with menopause.
Brisdelle contains the selective serotonin reuptake inhibitor paroxetine mesylate, making it unique from all other FDA-approved treatment for hot flashes which contain the hormones estrogen or progestin.
Around 75 percent of women experience hot flashes when they enter menopause, some women may suffer from it for years.
Hot flashes are intense feelings of warmth which can spread across the whole body – particularly the face and chest – making you sweat and your skin redden. Even though hot flashes aren’t life threatening they can still be extremely bothersome.
Hylton V. Joffe, M.D., M.M.Sc., director of the Division of Bone, Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research, said:
“There are a significant number of women who suffer from hot flashes associated with menopause and who cannot or do not want to use hormonal treatments.
Today’s approval provides women with the first FDA-approved, non-hormonal therapeutic option to help ease the hot flashes that are so common in menopause.”
The FDA approved the drug based on good results from two randomized, double-blind, placebo-controlled studies. A total of 1,175 postmenopausal women with moderate to severe hot flashes participated in the studies.
The women were given treatment for 12 weeks in one study and 24 weeks in the other.
Both study results demonstrated that Brisdelle was more effective at reducing hot flashes compared to placebo.
Side effects of Brisdelle include:
The drug is intended to be taken once a day before going to bed. As Brisdelle contains 7.5 mg of paroxetine, which other medications for major depressive disorder also contain (such as Paxil), the medications comes with a Boxed Warning about increased risk of suicide in children and young adults.
Another possible future form of non-hormonal treatment for hot flashes could be hypnosis. The results of a randomized, controlled study, published in the journal Menopause, found that hypnosis can minimize hot flashes by as much as 74%.
In addition, two daily servings of soy can reduce the frequency and severity of hot flashes by up to 26 percent, compared to placebo, according to findings published in Menopause: The Journal of the North American Menopause Society.
Written by Joseph Nordqvist