Regulatory FDA approves drug for night sweats and hot flashes...

FDA approves drug for night sweats and hot flashes treatment


The FDA announced on Friday that a new non-hormonal medication, Veozah, also known as fezolinetant, has been approved for patients who cannot or choose not to undergo hormonal therapy. While not as effective as estrogen or estrogen combined with progestin, Veozah is a promising alternative for those who suffer from vasomotor symptoms like intense heat, flushing, and sweating. The medication provides relief to women experiencing severe and moderate hot flashes, which is a typical symptom associated with menopause and can last for several years.

The hot flashes and night sweats that often accompany menopause can be debilitating and affect a person’s quality of life. For many years, hormone replacement therapy (HRT) has been the standard treatment for these symptoms. Despite its effectiveness in treating menopausal symptoms such as hot flashes, hormonal replacement therapy (HRT) can be dangerous for certain groups of women, including those with a history of breast cancer or a heightened risk of developing the disease. Therefore, a non-hormonal medication for treating hot flashes and night sweats is an important development in menopausal medicine.

Dr. Mary Rosser, director of Integrated Women’s Health at Columbia University as well as an assistant professor of women’s health in the same university’s Vagelos College of Physicians and Surgeons, said “I’m so excited about this FDA ruling. We’re talking about something that is going to be powerful.”

The newly approved pills will target moderate to severe hot flashes, which is the most common symptom associated with menopause. Hot flashes are known to last for years or even a decade and are experienced by numerous women in their 40s and 50s.

The recent approval of the new medication, fezolinetant, is a significant development for women who suffer from hot flashes and cannot or choose not to take hormonal therapy. One such patient, Diane Hoard, had been prescribed hormone therapy for her hot flashes, which worked initially but had to be discontinued after she was diagnosed with stage 1 breast cancer. Without the therapy, Hoard’s hot flashes returned and impacted her daily life. The new medication, marketed as Veozah, could be available in pharmacies within weeks, according to the drug’s maker, Astellas. 

Although the newly approved medication fezolinetant, marketed as Veozah, can alleviate vasomotor symptoms like hot flashes, it is not as effective as hormone replacement therapy. Results of a Phase 3 trial indicated that fezolinetant improved hot flashes in less than half of those who took it. The approval of the new medication will be beneficial for those who cannot or do not want to take hormonal therapy.

Overall, fezolinetant’s approval is a significant step forward for menopausal medicine. It provides a much-needed alternative for women who cannot or do not want to take hormonal therapy, and it will help many women regain a sense of normalcy in their lives. However, it is important to note that the medication is not as effective as hormone replacement therapy, and women who are considering taking it should discuss their options with their healthcare providers.

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