The US Food and Drug Administration has approved the first non-hormonal drug for treating hot flashes even though an advisory committee had voted against such an approval back in March.
The drug will be manufactured by Noven Pharmaceuticals and will be marketed under the name Brisdelle and contains low dosage of paroxetine, used in higher quantities in the antidepressant drug Paxil.
AdvertisementThe advisory committee had voted 10-4 recommending against an approval for the drug back in March, stating that while there was a need for a non-hormonal treatment for hot flashes, Noven's drug was only minimally effective.
Stating that there were a large number of women who did not want to use hormonal treatments for hot flashes, FDA's director of the F.D.A's division of bone, reproductive and urologic products Dr Hylton V. Joffe 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."