FDA Approves Breakthrough Drug For Menopausal Hot Flashes



FDA Approves Breakthrough Drug For Menopausal Hot Flashes

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The U.S. Food and Drug Administration (FDA) approved Veozah (fezolinetant), an oral medication designed to alleviate the discomfort of moderate to severe vasomotor symptoms, commonly known as hot flashes, caused by menopause. This approval marks a significant milestone as Veozah is the first neurokinin 3 (NK3) receptor antagonist to receive FDA approval for treating moderate to severe hot flashes resulting from menopause. By binding to and inhibiting the activity of the NK3 receptor, Veozah effectively regulates the brain’s control over body temperature.  

Dr. Janet Maynard, director of the FDA’s Office of Rare Diseases, Pediatrics, Urologic, and Reproductive Medicine, stressed the importance of this approval in improving the lives of women who have hot flashes. She acknowledged that the physical discomfort of menopausal hot flashes could affect a woman’s quality of life. According to Dr. Maynard, adding Veozah as a new therapy option will provide women with a safe and effective alternative to manage moderate to severe menopausal hot flashes.  

Menopause is a typical transitional time in a woman’s life between 45 and 55 and signals the end of menstruation. When a woman has not had her period for 12 months, she is considered to be in menopause. Estrogen and progesterone levels naturally decline throughout menopause. 

 Almost 80% of women suffer hot flashes during menopause, which can last several minutes and include symptoms such as perspiration, flushing, and chills.  

Hormone therapy is usually recommended to relieve hot flashes; however, some women cannot tolerate these prescriptions due to a history of vaginal bleeding, stroke, heart attack, blood clots, or liver disease. Veozah, unlike hormone replacement treatment, is not a hormone. Instead, it works by inhibiting the nerve impulses that cause hot flashes in menopausal women.  

Veozah prescription patients should take one 45-milligram pill orally once daily, simultaneously every day, with or without meals. Patients should take any missed or delayed doses as soon as they remember and return to their regular schedule the next day. 

Veozah successfully treated moderate to severe heat flashes in two 12-week randomized, placebo-controlled, double-blind phase 3 clinical trials. The 12-week study was followed by a 40-week extension study in which placebo individuals were re-randomized to receive Veozah. The participants’ average age was 54, and the studies lasted 52 weeks.  

The prescribing information for Veozah contains a warning concerning the chance of liver damage due to elevated hepatic transaminase. Before commencing Veozah medicine, liver function tests should be undertaken to determine the amount of any existing liver impairment. Regular bloodwork should be performed every three months during the first nine months of Veozah medication.

If you develop any symptoms of liver damage, such as nausea, vomiting, or a yellowing of your skin or eyes, get medical attention immediately. Veozah should be avoided by patients with cirrhosis, severe renal impairment, end-stage renal disease, and those using CYP1A2 inhibitors.  

The most commonly reported side effects of Veozah are abdominal pain, diarrhea, insomnia, back pain, hot flashes, and elevated hepatic transaminase levels. With the FDA’s approval of Veozah, women experiencing moderate to severe hot flashes linked to menopause now have another therapeutic alternative. 


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