The FDA has a news flash for women who suffer hot flashes. It has approved the first nonhormonal treatment for the condition, which affects up to 75% of women and can drag on for 5 years or more.
The FDA said on Friday it had approved Brisdelle from Noven Therapeutics, which is a unit of Hisamitsu Pharmaceutical. The decision was a bit of a surprise, Reuters reports. While the FDA staff recommended approval, a panel of experts in March voted not to recommend it, saying its risks outweighed its benefits.
The drug contains paroxetine, the same ingredient found in the popular antidepressant and antianxiety drug Paxil, and so carries a boxed warning about the risk of suicide associated with its use in children and young adults. Brisdelle contains 7.5 mg of paroxetine, less than Paxil, the agency said. A medication guide about the risk and other important information will be included with each refill.
Other treatments are approved for hot flashes, but they all contain estrogen alone or estrogen plus a progestin, and many women do not want to take those, the FDA pointed out. Hormonal treatments used to be commonplace, but their popularity fell off more than a decade ago after a large study tied them to an increased risk of breast cancer. Drugmakers, like Pfizer ($PFE), have spent years defending or settling litigation tied to that issue.