Veozah : FDA-Approved Medication for Hot Flashes in Menopausal Women

Women across the world have suffered from hot flashes, one of the major symptoms of menopause. Hot flashes can be a severe physical burden on women and can impact their quality of life. There are no major treatment options for hot flashes. However, recently the Veozah (Fezolinetant), an oral medication for treating moderate to severe symptoms of hot flashes, caused by menopause, has been approved by the U.S. Food and Drug Administration (FDA).⁽¹⁾

Let us read further and know more about the drug, how does it work, its side effects, and more.

Hot flashes are intense feelings of heat that are not caused by external sources. Hot flashes can make the skin red and can also result in sweating. Night sweats are common versions of hot flashes and they can also interrupt sleep. Hot flashes cause a reduction in the flow of blood to the brain.

Women start experiencing menopause between 45 years to 55 years and roughly in 80% of menopausal women, hot flashes are common.⁽²⁾ Hot flashes can last from a few seconds to two minutes. Around 25% to 30% of women experiencing hot flashes have severe ones, which means that they are having around eight to nine hot flashes per day. This is highly frustrating.

To address the common concern of menopause, that is symptoms of hot flashes, Astella Pharma Inc. has recently announced that the U.S. FDA has approved Veozah as a treatment for hot flashes and night sweats that are commonly experienced during menopause. Fezolinetant is the first-of-its-kind drug, sold under the brand name Veozah, which is approved by the U.S. Food and Drug Administration for treating moderate to severe hot flashes.

Before Veozah, the main treatment option for hot flashes related to menopause was hormone replacement therapy (HRT) and this was not possible for everyone.

Veozah is an oral medicine and only a single pill in a day, which is hormone-free, and is quite promising in providing menopausal women relief from hot flashes, especially women who cannot take hormone trap because of their other underlying health conditions like a prior history of heart attacks, strokes, or blood clots.

The approval of Veozah for hot flashes was based on data from the SKYLIGHT 2 trial, the results of which were published in the Journal of Clinical Endocrinology and Metabolism and were also presented at the annual meeting of the Endocrine Society.⁽³⁾

In the two-phase trial, the participating women were assigned to receive either 30 mg or 45 mg of fezolinetant or placebo quite randomly. After 12 weeks, the placebo group’s women were re-randomized to fezolinetant for a safety study for another next 40 weeks.

The participants in the study were women who were between the age of 40 years to 65 years, and they were experiencing an average minimum of seven moderate-to-severe hot flashes in a day. It included 120 sites in Europe and North America.

At 12 weeks, both fezolinetant and placebo patients experienced reductions in their moderate to severe symptoms of hot flashes approximately 60%, and also a significant reduction in the severity of the symptoms.

Veozah is the first neurokinin 3 (NK3) receptor antagonist that has been approved by the Food and Drug Administration for treating hot flashes experienced during menopause. This drug works by binding to and blocking the activities of the Neurokinin 3 receptor, which plays a major role in the brain’s function of regulating body temperature.

Some women who experience symptoms of hot flashes and also have a history of vaginal bleeding, heart attack, stroke, liver disease, or blood clots, are not suitable to take hormone treatments. Veozah, the newly approved drug is not a hormone. This targets the neural activity which causes hot flashes experienced by women during menopause.

Veozah works by targeting the temperature control center of the brain to decrease both the frequency and also intensity of hot flashes. During hot flashes, the thermostat gets unregulated and Veozah resets that thermostat and significantly drops the number of hot flashes.

Patients who are taking Veozah should take only one pill of 45 mg orally once a day on an empty stomach. The medicine should be taken at the same time every day. If you miss a dose or did not take the pill at the regular time, try to take it as soon as possible and get back to the regular schedule the next day.

Serious side effects of taking Veozah include liver injury. Due to the small risk of liver damage from the drug, the Food and Drug Administration recommends that doctors or providers conduct a blood test before prescribing the drug to anyone and then every three months for the first nine months of treatment.⁽⁴⁾

Some other common side effects of Veozah include diarrhea, abdominal pain, back pain, insomnia, and elevated hepatic transaminases.

Millions of menopausal women experience symptoms of hot flashes every day. Now, with the approval of the new drug Veozah for hot flashes, it could bring a sigh of relief to many of them. It would help women who cannot go for hormone replacement therapy.

Note: One thing should be noted down even if left untreated, hot flashes will go away eventually.

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Also Read:

• What Causes Hot Flashes?
• How Long do Hot Flashes Last|How to Stop Hot Flashes?
• What Causes Hot Flashes During Pregnancy & How to Get Rid of it?
• Triggers for Hot Flashes during Menopause