The U.S. Food and Drug Administration just approved Brisdelle (paroxetine) for the treatment of hot flashes due to menopause. This is the first non-hormonal drug designed to treat hot flashes, one of the most bothersome symptoms of menopause.
According to a U.S. Food and Drug Administration (FDA) news release, paroxetine contains the selective serotonin reuptake inhibitor paroxetine mesylate.
The move was surprising because an advisory committee to the FDA voted 10 to 4 in March against approval, stated the New York Times (NYT).
The panel likely disapproved of the drug, Dr. Tara Shirazian, a gynecologist at Mount Sinai Hospital explained on "CBS This Morning," because the scientific data was likely not compelling enough.
However, Shirazian pointed out to CBS News, Brisdelle has been used for years among OB-GYNs for the off-label indication to treat symptomatic hot flashes. It has been prescribed as the antidepressant drug Paxil, but now, the new FDA-approved drug is a lower dosage.
Other FDA-approved products for hot flashes contain estrogen alone or estrogen plus a progestin, wrote WSJ.
Hormone therapy was once a standard treatment to replace the hormones the body no longer makes after menopause. But its use dropped after 2002, when a large clinical trial showed the therapy increased the risk of heart disease and breast cancer, said Reuters.
Around 75 percent of women experience hot flashes when they enter menopause. Some may suffer from them for years, wrote MNT.
Women in the Brisdelle clinical trials started with a median of about 10 hot flash episodes a day. NYT reported that after 12 weeks those who took the drug had a median of nearly six fewer hot flash episodes a day, compared with a reduction of four or five episodes a day for those receiving the placebo.
"There are a lot of women who can't use hormone replacement therapy, and we understand more and more about the issues related to estrogen and progesterone each day," Shirazian told CBS News.