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FDA Gives Approval to New Drug for Treating Menopause-Related Moderate to Severe Hot Flashes

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FDA Gives Approval to New Drug for Treating Menopause-Related Moderate to Severe Hot Flashes

The FDA has granted approval for Veozah (fezolinetant), an oral medication designed to treat moderate to severe vasomotor symptoms, including hot flashes, associated with menopause. This marks the first FDA-approved neurokinin 3 (NK3) receptor antagonist for treating hot flashes caused by menopause. Veozah functions by binding to and inhibiting the activity of the NK3 receptor, which is involved in regulating body temperature in the brain.

Menopause is a natural and gradual change that occurs in a woman’s life, usually between the ages of 45 and 55, when her menstrual periods stop. This transition is often referred to as “the change” or “the change of life”. As a woman’s body goes through menopause, it gradually produces lower levels of the hormones estrogen and progesterone. Menopause is confirmed when a woman hasn’t had a menstrual period for 12 consecutive months. Hot flashes, experienced by about 80% of menopausal women, can cause episodes of sweating, flushing, and chills that can last for several minutes.

For women who experience hot flashes and have a history of vaginal bleeding, stroke, heart attack, blood clots or liver disease, hormone therapies may not be an option. Unlike hormone therapies, Veozah is not a hormone-based medication. It works by targeting the neural activity that causes hot flashes during menopause. Patients should take one 45 milligram pill of Veozah orally, once a day, with or without food. It is recommended to take the pill at the same time each day. In case a dose is missed, patients should take it as soon as possible and resume their regular schedule the following day.

Each of the first 12-week, randomized, placebo-controlled, double-blind segments of two phase 3 clinical trials showed that Veozah was effective in treating moderate to severe hot flashes. Following the initial 12 weeks, women who were on placebo were re-randomized to Veozah for a 40-week extension study to assess safety. The trials ran for a total of 52 weeks. The average age of participants in the trials was 54 years old.

Veozah comes with a warning for liver injury, as indicated in the prescribing information. Patients are advised to undergo liver function tests before starting the medication. During the first nine months of use, patients are recommended to have routine bloodwork every three months to check for liver damage. If patients experience symptoms such as nausea, vomiting, or yellowing of the skin and eyes, they should seek medical attention immediately. Veozah is contraindicated in patients with known cirrhosis, severe renal damage, or end-stage renal disease. Additionally, it should not be taken with CYP1A2 inhibitors.

Astellas Pharma US, Inc. has been granted approval for Veozah, which may cause common side effects such as abdominal pain, diarrhea, insomnia, back pain, hot flush, and elevated hepatic transaminases.

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Siya
Siya has a master’s degree in Marketing and editor with passion. He holds 7 years’ experience in this field. She holds a keen interest in the know-how of what is brewing in healthcare and science.

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