Treating hot flashes without hormones

What to know about a new FDA-approved, non-hormonal treatment for hot flashes
Hot flashes are the most common symptom of menopause, occurring in 75% of all women and often persisting for years. About 68% of women experience hot flashes and night sweating for more than 2 years and 35% for over 5 years.¹

For some women, hot flashes are mild, infrequent, and do not require treatment. Others have more intense and frequent hot flashes that negatively affect their quality of life, including sleep interruption, mood changes, difficulty concentrating, and interference with daily activities. A recent study by the Mayo Clinic reported that menopause symptoms, including hot flashes, result in a loss of work time by women valued at an estimated $1.8 billion, annually.²

Here’s a brief review the existing treatments and a newly approved, non-hormonal treatment option.

Existing treatment options
There are relatively few medically proven treatments for hot flashes, resulting in an unmet need for menopausal women.

Hormone therapy is effective in managing hot flashes but some studies have suggested that for some women, it can increase the risk of certain cancers and cardiovascular events.3 For example, in women with certain risk factors like a high risk of breast or endometrial cancer, heart disease, stroke, or blood clots, the benefits of hormone therapy may not outweigh the risks.³

Until recently, the only non-hormonal, FDA-approved therapy was the anti-depressant paroxetine (Brisdelle), but this treatment is not as effective as hormone therapy.⁴

Veozah, a new non-hormonal treatment for hot flashes
In May 2023, the FDA approved a new non-hormonal treatment, fezolinetant (brand name Veozah, pronounced Vee-oh-zah) for the treatment of moderate-to-severe hot flashes caused by menopause.⁵ This approval provides a new option for women who cannot take hormone therapy.

Veozah targets the neural activity that causes hot flashes. It works by blocking a receptor called NK3, which plays a role in the brain’s regulation of body temperature. Veozah is prescribed as one 45mg pill, taken once a day.⁵ Veozah was shown to be effective in a clinical trial called SKYLIGHT-2, where 48% of women taking the 45mg dose reported that their hot flash symptoms were moderately or much better, compared with 36% in the placebo group.⁶

The most common side effects of Veozah were abdominal pain, diarrhea, insomnia, back pain, hot flashes, and elevated liver values, but none of these side effects were reported to be serious. However, due to the elevated liver values, the FDA has included a warning for liver injury in the prescribing information, which notes that patients should undergo baseline blood work before starting Veozah to test for liver infection or damage and should have follow-up blood work after 3, 6, and 9 months of treatment.⁵

The manufacturer of Veozah, Astellas Pharma US, announced that a one-month supply will cost $550, before discounts. It is not yet covered by insurance.

References

1. Lugo, T. & Tetrokalashvili, M. Hot Flashes. in StatPearls (StatPearls Publishing, 2023).
2. Faubion, S. S. et al. Impact of Menopause Symptoms on Women in the Workplace. Mayo Clinic Proceedings 98, 833–845 (2023).
3. Treatment of Symptoms of the Menopause: An Endocrine Society Clinical Practice Guideline | The Journal of Clinical Endocrinology & Metabolism | Oxford Academic. https://academic.oup.com/jcem/article/100/11/3975/2836060.
4. Orleans, R. J. et al. FDA Approval of Paroxetine for Menopausal Hot Flushes. New England Journal of Medicine 370, 1777–1779 (2014).
5. Commissioner, O. of the. FDA Approves Novel Drug to Treat Moderate to Severe Hot Flashes Caused by Menopause. FDA https://www.fda.gov/news-events/press-announcements/fda-approves-novel-drug-treat-moderate-severe-hot-flashes-caused-menopause (2023).
6. Johnson, K. A. et al. Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. The Journal of Clinical Endocrinology & Metabolism dgad058 (2023) doi:10.1210/clinem/dgad058.