Veozah: Non-hormonal Hot Flash Drug is FDA Approved

By Deborah Jeanne Sergeant

As of June 1, the FDA approved the first drug in its class to treat menopausal hot flashes. Veozah (fezolinetant) is an oral medication indicated for moderate to severe hot flashes.

If Veozah is classified as a “tier 2” medication, most insurance will cover it with a moderate co-pay for patients.

Barb Madison, pharmacist at Parker Pharmacy in Buffalo, thinks that insurance companies could classify it “more as a cosmetic thing than quality of life” and not even cover it.

That would mean that it could cost as much as $660 out of pocket to quell hot flashes and night sweats.

But for those who could afford it, the cost may be worth it.

“It’s a quality of life issue,” said Michelle Chin, a physician with Rochester Regional Health. “Some women have terrible hot flashes and are up all night. It’s embarrassing. It’s not fun when work colleagues say, ‘Are you OK?’ because your face is flushed. It’s so exciting to launch this drug. Women with hot flashes and night sweats have been suffering quite a bit.”

Although hormone therapy is well tolerated for some women, others do not want or cannot have it. Hormone therapy has been linked with an increased risk of breast can-

Could a Nitroglycerin Patch Ease Hot Flashes?

Anew study on using nitroglycerin patches to help women with frequent hot flashes caused by menopause has delivered mixed results.

The benefits of wearing these patches — long used as chest pain medication — were modest. They also were short-lived, with any benefits appearing to wear off over time, according to researchers from the University of California, San Francisco (UCSF).

Still, this approach to finding new treatments may be helpful.

“The bottom line is that our study doesn’t allow us to recommend nitroglycerin skin patches as a strat- egy for consumers to suppress hot flashes in the long term,” said lead author Alison Huang, an internal medicine physician at UCSF Health and a clinical epidemiologist. cer and cardiovascular disease.

“But our study suggests that there may be promise in this overall approach to treating a common condition in midlife women. The menopause field is still lacking in effective treatment approaches that don’t involve hormones,” Huang said in a UCSF news release.

Huang’s team tested the benefits of continuously wearing a nitroglycerin patch for menopausal women experiencing at least seven hot flashes a day.

Colleague Olivia Higgins, physician, added that the introduction of Veozah “shows how there is more discussion in the media and among people about the importance of how hot flashes interrupt quality of life. More research is going into how to improve this for women. There are multiple options beyond hormonal therapy.”

Higgins works at Rochester Regional Health. She likes the opportunity to offer more choices to patients, especially one that is so effective as Veozah.

Chin said that by week one, those taking Veozah experience a 50% reduction of hot flashes and that continues to improve by week 12. The diversity of the trial, both in the ethnicity and BMI of the participants, bodes for a much broader efficacy than trials that include fewer types of women.

“After 12 weeks, the women who’d been on placebo switched to Veozah and they also had the benefit of reducing their symptoms,” Chin said. “The placebo effect is 30% of patients seeing a difference. I like the crossover study.”

Higgins encourages anyone interested in Veozah to discuss their health issues and other medications with a healthcare provider to determine what is best for them.

Treating hot flashes is “definitely a big part of my practice,” said Carol Peterson, physician and assistant professor at URMC. “Some people tolerate them nicely, but about 40% of women find them very bothersome.”

She said that Veozah is a different class of medication than previous drugs used to treat hot flashes. It works by interrupting the pathways in the brain related to hot flashes, which is a different mechanism for reducing hot flashes.

“We have tried many other options in the past,” Peterson said. “Other drugs are marginally helpful. Antidepressants can help, and depression is often a side effect of menopause. This seems to be the most effective with the least side effects. It seems to be very effective for women who don’t want estrogen.”

Veozah is contraindicated for women with liver disease or liver problems. Patients are monitored for liver function.

Sleepiness is another side effect. Many menopausal women struggle with sleep. Some women experience nausea and gastrointestinal upset.

This study enrolled 141 women aged 40 to 62 who were in late menopausal transition or postmenopausal. The women wore either the nitroglycerin or placebo patches for 24 hours a day, recording their hot flashes at weeks five and 12. The researchers found that the benefits of nitroglycerin compared to placebo did not extend past 12 weeks. Some women also experienced headaches.

“Nitroglycerin has been used for decades to treat chest pain in patients with coronary disease because it can increase blood flow to the heart when used for only 12 hours at a time,” Huang said.

“But lab studies suggested that if nitroglycerin is used continuously, it could prevent or suppress the type of rapid, increased blood flow under the skin that causes sensations of heat and flushing during hot flashes during menopause,” she added. “In this line of research, we repurposed a medication that has been used for close to a century for a different indication.”

Those symptoms, including intense flushing and sweating, are common in menopause. More than two-thirds of menopausal women in the United States experience them, sometimes for years.

Hormone therapy can be highly effective at reducing or suppressing these symptoms. Yet, that comes with risks, including for some cancers, and women have long asked for alternatives.

Most treatments for hot flashes target brain mechanisms. This one was targeted at blood vessels throughout the body.

The trial was supported by the U.S. National Institute on Aging, with the findings published June 5 in JAMA Internal Medicine.