New FDA-approved drug could bring relief from hot flashes for millions of menopausal women

It is a difficult fact of life for roughly 75% of all women going into and through menopause: They suffer from hot flashes, night sweats, and chills, which often start with perimenopause in their mid to late 40s. It can be a decades-long struggle with symptoms that impact a woman's quality of life and productivity.

"It affects everything, so it is not just your sleep but also your mood," says Camille Moreno, DO, NCMP, medical director of the Midlife Women's Health and Menopause Program at University of Utah Health. "It affects your work productivity and relationships. If you are not overall feeling like yourself, you are not demonstrating your best self, whether at work or at home."

Now, a one-of-a-kind treatment for hot flashes and night sweats (also known as vasomotor symptoms) will be available to women with a prescription from their medical provider. The non-hormonal drug fezolinetant or fezo, sold under the brand name Veozah was approved by the U.S. Food and Drug Administration in May. Moreno thinks it will be a game-changer.

"I have been waiting for Veozah to be approved and out on the market for the last four years, so finally it is here," Moreno says. "It really is a first in its class, so it is novel because we have not had anything previously approved for moderate to severe vasomotor symptoms that acts on the same mechanism as Veozah."

Moreno described the unique way Veozah operates on the human body as an on/off switch. "It blocks a particular area in the brain specifically dealing with chemicals that help regulate body temperature," she says. During menopause, a woman's declining levels of estrogen can disrupt the balance between a chemical known as neurokinin 3 (NK3) and estrogen, causing the hypothalamus or brain's thermostat to signal an overheating of the body.

According to Moreno, that's when Veozah takes over. "It blocks (or turns off) that neurokinin (NK3) at its receptor, and that is how it decreases hot flashes," she says. "So, women who are on hormone replacement therapy (HRT), or those who are not good candidates for hormone therapy, can both benefit from Veozah."

In fact, those women who cannot take or have been warned against using HRT can benefit the most from Veozah since it is a non-hormonal drug. "These are women with a history of estrogen-sensitive cancers such as breast cancer, blood clots in the legs or the lungs, and those who have heart disease, so women who have a history of stroke or a heart attack," Moreno says.

Veozah is also extremely effective for women interested in starting or continuing some type of menopausal hormone therapy more than a decade after their last menstrual period or once they have reached their early 60s. This is because recent studies show that after your 60s and/or ten years after menopausal onset, "use of estrogen can increase your risk of a cardiovascular event," Moreno says. "So, estrogen could potentially increase your risk of stroke and heart attack."

There were 12- and then 40-week trials of Veozah, which collectively involved more than 3,000 women. Moreno described the reported results of those studies as impressive. "Veozah showed a decrease in hot flashes and night sweats as early as the first day women took the medication," she says. "So, with that type of new mechanism at the level of the hypothalamus, it has a quicker efficacy compared to estrogen therapy. With estrogen therapy, we say two to four weeks and, in some women, even longer, up to three months, for the patient to notice a difference."

Moreno is especially excited about the impact that use of a non-hormonal drug like Veozah could have on women of color. "Hispanic and African American women tend to experience the vasomotor symptoms (hot flashes and night sweats) earlier on," she says. "They tend to have earlier perimenopause, suffer more from severe symptoms, and suffer longer as well."

To date, there are no studies comparing the efficacy of Veozah to estrogen or HRT, which is widely known to reduce the frequency of hot flashes by 75%. We also know a lot more about the long-term health benefits and side effects of HRT. It will take much longer, after Veozah has been on the market for several years, to better understand the benefits and possible adverse side effects of the drug.

In testing, Moreno suggested that researchers found a small percentage of women who experienced elevated liver enzymes while using Veozah. "There is that potential chance that it could hurt or damage your liver," she says. "However, it happened in a very small number of women in the study. But that is why the drug will carry a warning that if you have any liver conditions, you should talk to your doctor before being prescribed Veozah or taking it. And you do have to get liver function testing before starting the drug and then at three months, six months, and nine months."

Of course, as with any prescription drug, cost is a factor, and Veozah needs to be affordable if the greatest number of women are going to utilize it. Once the drug is available in pharmacies, the wholesale price will be $550 for a 30-day supply. Moreno has spoken with representatives of the Japanese pharmaceutical company Astellas, which produces Veozah, and they pledge to work on ways to bring the cost of the drug down.

"They are working on agreements with pharmacies so that women don't have to pay that wholesale cost as well as working with insurance coverage plans," Moreno says. "And for those who don't have insurance coverage, women can reach out to a hotline number (1-866-239-1637) for information on savings cards and coupons."

She emphasizes the importance of ensuring that women who can benefit from using Veozah have every opportunity to do so. "Women should not have to pay hundreds of dollars for the drug but should be able to obtain it at a lower cost," she says.

Related topics