The Food and Drug Administration announced Friday that it has approved a new type of drug to treat moderate to severe hot flashes.That could provide relief to the millions of women who don’t want to take hormone therapy to treat their symptoms.
Drugmaker Astellas said the pills – known as Phaseolinant, Veozah – could be available in pharmacies within three weeks. The medicine is taken once a day.
It works by blocking a chemical in the brain that affects how body temperature is regulated. Doctors cite the drug as a milestone in addressing the root cause of vasomotor symptoms of menopause.
About 80% are faced by womenthey are . Some can manage them with simple lifestyle changes, such as avoiding alcohol and dressing in layers.
But hot flashes can be debilitating for some, with quick and unexpected episodes forcing women to miss work and upskilling their lives. In one study, up to 46% of women experienced moderate or severe hot flashes over the years.
“Hot flashes resulting from menopause can be a serious physical burden on women and can affect their quality of life,” the FDA’s Dr. Janet Maynard said in a statement announcing the approval.
Astellas Pharma US, Inc.
Fezolinetant is not the first drug approved by the FDA to treat menopause, but it is different from the drugs that have come before.
For decades, hormone replacement therapy has been the treatment recommended by experts for severe symptoms of menopause.
But use of these treatments declined sharply in 2002 after findings from the government-backed Women’s Health Initiative suggested that taking a combination of estrogen and progestin could increase the risk of worrisome conditions such as breast cancer and heart disease.
That’s led experts to make their guidelines, though they say the evidence shows the benefits still outweigh the risks for many women struggling with symptoms.
An antidepressant, paroxetine, is the main non-hormone treatment option available for women. But its approval was controversial and experts considered it less effective.
While no true head-to-head studies have been published comparing phaseolinant against menopausal hormone therapy, or MHT, research so far on the drug suggests it may be a promising option.
“In the short term, the safety and tolerability of Phaseolinent and MHT appear comparable. However, long-term use of MHT carries a serious increased risk,” the Institute for Clinical and Economic Review wrote in a report last year.
Other options may soon become available for this market, which Astellas estimates could reach $1 billion in 2016. Drug maker Bayer is in final phase 3 trials for its drug, called elizanetant, which takes a similar approach.
“The introduction of a new molecule for the treatment of moderate to severe menopausal hot flashes will provide an additional safe and effective treatment option for women,” Maynard said.