What you need to know about new treatments for hot flashes

The Food and Drug Administration on Friday approved a new non-hormonal oral drug designed to treat menopausal hot flashes under the brand name Veozah. Dr. Janet Maynard, director of the FDA’s Office of Rare Diseases, Pediatrics, Urology and Reproductive Medicine, said in a statement that the drug offers women “a safe and effective treatment option.”

Hot flashes, also called vasomotor symptoms, affect about 75% of menopausal and perimenopausal American women. A growing body of evidence suggests that this sudden and overwhelming feeling of heat in women can have a serious impact on quality of life and productivity. Studies have found that black women have more severe and frequent hot flashes over a longer period of time.

But there are few safe and effective treatments for hot flashes, says Stephanie Fabion, M.D., medical director of the North American Society of Menopausal Medicine and director of the Mayo Clinic Women’s Health Center. Hormone therapy is the most effective treatment for women under her 60s, but it carries risks for women with certain health conditions. Misconceptions about it, she said, are largely rooted in a 2002 study that has since been challenged, driving many other women away from the study.

Only one other non-hormonal therapy has been proven to effectively manage hot flashes. It’s paroxetine used primarily to treat depression, but it’s also been approved by the FDA for use in menopause symptoms.

Dr. Lauren Streicher, M.D., clinical professor of obstetrics and gynecology at Northwestern University, said decades of limited treatment options had created a huge “unmet need,” prompting Japanese pharmaceutical companies to He said that Veozah, manufactured by Astellas Pharma, is a breakthrough and has been long awaited. Director of the Northwestern Medical Menopause Center.

“Given the impact of vasomotor symptoms on work, cognitive function, sleep and quality of life, it’s interesting to see other options available,” she says. “This is what we have expected for a long time.”

About a decade ago, researchers identified neurons in the brain known as KNDy neurons that regulate body temperature and found that they were primarily controlled by estrogen. When a woman goes through menopause and estrogen levels drop, “these neurons go into overdrive,” making the body feel hotter than it actually is, triggering a series of cooling phenomena such as sweating, Streicher says. said Dr.

Veozah contains a compound called phasolinetant, which binds to these neurons and “calms them,” Dr. Streicher said.

Astellas conducted three trials of Veozah in trials in Canada, the United States and European countries, involving more than 3,000 women with moderate or severe hot flashes. Compared to placebo, the drug significantly reduced the severity and frequency of hot flashes in women who took one tablet daily.

Many women taking this drug reported changes by week 4. Some women reported feeling changes in as little as a week, said Dr. Nanette Santoro, a professor of obstetrics and gynecology at the University of Colorado School of Medicine, who served as a scientific advisor to Astellas during trials of the drug.

No studies have yet compared the efficacy of fesolinetant to that of estrogen (which can reduce the frequency of hot flashes by 75 percent, according to Dr. Fabion), but it appears to be more effective than paroxetine.

The trial included women between the ages of 40 and 65, and the drug was effective across those age groups. But it may be especially helpful for women over the age of 60. Starting hormone therapy at that age is considered risky and “may be a very good option” for such women, said Streicher, who was not involved in the study. However, he reconsidered the findings.

“Another good thing about the clinical trial was that it included a wide range of women, including black women, Asian women, and Latino women,” she says. “And it worked for black women as much as it did for white women. That’s a huge thing.”

One of the main concerns going into this trial was liver toxicity. Similar versions of the drug made by other companies were found to have serious side effects and were stopped from trials, Santoro said.

Twenty-five women showed elevated liver enzymes across the three trials of the drug, according to the FDA’s safety statement. For this reason, women with known liver damage should avoid taking the drug, and the FDA recommends having a blood test before starting the drug to screen for liver damage. increase. It is also not safe for patients with known renal insufficiency or kidney disease.

Dr. Fabion said there are “a lot of unknowns” about the drug, particularly its effects on “heart health, bone health, sexual health, mood symptoms or weight.” He added that it will be difficult to fully evaluate the drug until it is on the market and more people are using it for the long term. Dr. Fabion noted that estrogen is the only one proven to provide long-term health benefits beyond alleviating hot flashes.

The company said the product will be available in pharmacies within three weeks at a price of $550 for a 30-day supply.

Dr. Fabion said the price is prohibitive and may not be covered by insurance companies. “It has to be affordable so that women can really take advantage of it,” she said.

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