The U.S. Food and Drug Administration on Friday approved a nonhormonal treatment for hot flashes for the first time -- despite an outside advisory panel’s previous determination that the drug in question was only a marginal improvement over placebo.
Hot flashes, also known as vasomotor symptoms, strike up to three-quarters of post-menopausal women. They are not seriously threatening but can cause discomfort and disruption of sleep. Current FDA-approved treatments for hot flashes contain either estrogen or estrogen plus the hormone progesterone, but many women cannot or do not want to use hormonal treatments.
There are some studies that suggest hormonal treatments can raise a woman’s risk for breast cancer and heart problems. The active ingredient of the newly approved Brisdelle, made by Miami's Noven Pharmaceuticals Inc., an American subsidiary of Japan’s Hisamitsu Pharmaceutical Co., is a selective serotonin reuptake inhibitor, or SSRI, called paroxetine -- the same as anti-depressant medications Paxil and Pexeva (another Noven-made medication).
Brisdelle, however, contains a lower dose of paroxetine than anti-depressives. The medicine is made to be taken once daily before going to bed.
The FDA’s decision comes nearly four months after an advisory panel recommended that the agency reject Brisdelle and a competing nonhormonal hot flash treatment from Depomed that contained the anti-seizure ingredient gabapentin. At the time, the panel said that both medicines did not offer significant enough benefits to patients. Brisdelle was rejected by the panel by a vote of 10 to 4.
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“The FDA does not have to follow the advice of its advisory panels,” the New York Times noted back in March. “But it would be highly unusual for the agency to clear a drug after a strongly negative committee vote.”
Brisdelle was established to be safe and effective based on two studies that examined a total of 1,175 postmenopausal women that were experiencing at least 50 to 60 hot flashes per week when the study began. While the studies showed that Noven’s drug does reduce the number of hot flashes, the actual advantage when the drug was compared to the placebo -- less than one less hot flash per day in one of the trials and less than two fewer hot flashes per day in the other -- was not significant enough to justify the possible side effects, according to the advisory committee. Brisdelle’s main ingredient, as with anti-depressants, carries a risk of suicidal thoughts.
But some doctors told the committee that women are clamoring for hot flash treatments and are growing desperate. If there are no nonhormonal options available, they may turn to herbal supplements or other therapies of questionable effectiveness.
These women “are begging for alternatives,” Baltimore OB-GYN Andrew London told the advisory committee in March, according to the Times. “They will get help on their own without us.”
How Brisdelle works to reduce hot flashes is still unknown. The most common side effects seen in patients were fatigue, nausea and headaches.
"The FDA views paroxetine as a useful treatment option [for hot flashes] with a positive benefit/risk assessment when used according to the label," agency spokesperson Andrea Fischer wrote in an email.