Hot flashes, flushing, and night sweats are common symptoms of menopause and can disrupt your daily life as well as your sleep. These symptoms can significantly decrease your quality of life. Fortunately, Fezolinetant, a new medication released in 2023, may offer relief for many women and people assigned female at birth (AFAB).
This article explores Fezolinetant’s mechanism of action, clinical trials, FDA approval process, and its potential impact on healthcare.
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Understanding Fezolinetant
Fezolinetant, which goes by the brand name Veozah®, is a first-in-class medication for the treatment of moderate to severe vasomotor symptoms of menopause.
What is Fezolinetant?
Fezolinetant belongs to a class of medications called neurokinin 3 (NK3) receptor agonists. This medication is approved by the Food and Drug Administration (FDA) to treat hot flashes which are moderate to severe. This medication is currently the only one available in this class.
Mechanism of Action
As previously mentioned, Fezolinetant is an NK3 receptor agonist. This means that the medication activates the NK3 receptors. NK3 is responsible for controlling the release of certain hormones that help regulate the menstrual cycle, specifically follicle-stimulating hormone (FSH) and luteinizing hormone (LH).
Fezolinetant is a nonhormonal therapy for the treatment of menopause. Studies show that it is significantly more effective than other nonhormone therapies, such as antidepressants and gabapentin.
Who Can Benefit?
Menopause is a transitional period where a woman or person AFAB stops having periods and exits her reproductive years. Menopause is defined as the absence of periods for at least a year without another cause. During perimenopause, people may have symptoms, but periods may not have completely stopped. Many people have no symptoms during menopause, but others have symptoms that can have significant impacts on quality of life. Some of the symptoms of menopause/perimenopause include:
- Hot flashes
- Night sweats
- Insomnia
- Mood swings or irritability
- Worsening premenstrual symptoms
- Irregular periods
- Vaginal dryness
- Urinary symptoms
- Breast tenderness
- Trouble concentrating
- Changes in sex drive
- Joint and muscle pain
- Changes in hair texture or amount
- Weight gain
The symptoms of menopause may start as much as 10 years prior to periods stopping altogether.
Fezolinetant specifically targets hot flashes and night sweats. These symptoms are vasomotor symptoms. Changes in hormone levels during menopause can change the thermostat in your brain (the hypothalamus) which can make your body over-react to slight changes in body temperature resulting in symptoms such as hot flashes. If hot flashes are interfering with your quality of life, Fezolinetant may be for you.
Fezolinetant’ s FDA Approval Journey
Fezolinetant was approved by the FDA in 2023. Let’s take a look at the steps it took to get to approval.
Clinical Trials and Research
Fezolinetant was first entered into the clinical trials database in 2019, and recruitment began in August. These phase 2 clinical trials demonstrated efficacy for treating the symptoms of menopause. Phase 3 clinical trials started in 2023 and further added to the evidence of the medication’s safety and efficacy.
FDA Review Process
Fezolinetant started the FDA review process in August of 2022 after being submitted in June of that year. The medication was granted priority review designation. In September 2024, a warning was added regarding the potential for rare but serious liver injuries related to the use of fezolinetant. In December 2024, this was escalated to a Boxed Warning.
Official Approval Announcement
The FDA announced the approval of Fezolinetant on May 12, 2023. As part of the press release, Dr. Janet Maynard, director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, a part of the Center for Drug Evaluation and Research, part of the FDA, stated, “The introduction of a new molecule to treat moderate to severe menopausal hot flashes will provide an additional safe and effective treatment option for women.”
Dosage and Administration
Now that we’ve established that Fezolinetant is effective, let’s discuss how it is administered and dosed.
Recommended Dosages
Fezolinetant has one approved dose. It is dosed as a 25mg tablet once daily.
How to Administer
Fezolinetant can be taken with or without food and should be taken at around the same time every day. If you miss a dose, you should take it as soon as you remember unless your next dose is due within 12 hours. It should not be chewed or crushed.
Safety and Precautions
Like any medication, Fezolinetant can have side effects. Here are some things you may want to watch for.
Potential Side Effects
Some of the potential side effects of Fezolinetant include:
- Abdominal pain
- Diarrhea
- Insomnia
- Back pain
- Hot flushes
- Elevation of liver function tests
In clinical trials, each of these side effects was present more often in patients taking 45mg of Fezolinetant than in those taking a placebo.
Drug Interactions
Fezolinetant has the potential to interact with several medications. As with any medication, you should make sure to discuss all medications and health conditions you take with your healthcare provider when you’re considering starting a new medication. There are several medications that Fezolinetant may interact with. Some of these medications include:
- Antiviral medications such as acyclovir
- Hormone medications such as estradiol, ethinyl estradiol, estetrol, drospirenone, nomegestrol, norelgestromin, norethindrone, norgestimate, levonorgestrel, medroxyprogesterone, and norgestrel
- Antidepressants such as fluvoxamine
- Antibiotics such as ciprofloxacin
- Antiacids such as cimetidine
- Gout medication such as allopurinol
This is not an exhaustive list of potential drug interactions. Before starting Fezolinetant, discuss your medication list with your healthcare provider and your pharmacist to ensure that your other medications won’t interact.
Precautions and Contraindications
Fezolinetant should be avoided in people who have severe or end-stage kidney disease. Because of the potential to worsen liver function, it should not be used in people with cirrhosis or other liver diseases. Other people who should not use Fezolinetant are those who are on other medications that are metabolized using the CYP1A2 system in the liver.
Patient Counseling and Education
If you’re considering Fezolinetant or have been prescribed this medication, there are several things to keep in mind.
Key Counseling Points
Fezolinetant is very effective, and because it is not a hormone-containing medication, it may be used in people who cannot take hormone replacement therapy for their menopause symptoms, such as those who smoke or those who have had a stroke, heart attack, or blood clots.
Before starting Fezolinetant, it is important to talk with your healthcare provider about all medications you are taking as well as any medical conditions you have in order to avoid potential side effects or complications. Like any medication, Fezolinetant works best if taken consistently.
Monitoring and Follow-Up
People who take Fezolinetant should have their liver function checked prior to taking the medication and again at 3, 6, and 9 months after starting therapy. If liver function increases more than 5 times above baseline or more than 3 times above baseline with an increase in bilirubin levels, then the medication should be discontinued. If liver function rises moderately, more frequent labs may be needed until the levels return to normal.
If you develop nausea, vomiting, itching, jaundice, dark urine, abdominal pain, or pale stools, you should seek immediate medical attention as this could indicate liver damage.
Educational Materials
If you want more information about Fezolinetant, you may want to visit the patient website for the medication where you can get answers to frequently asked questions as well as information on programs to decrease the cost of the medication.
Long-Term Use and Potential Benefits
As a new medication, there is less information about the long-term use of Fezolinetant.
Efficacy Over Time
After its initial approval, Fezolinetant studies continued, and phase 3 trials followed patients who had been on the medication for at least 1 year. The initial phase 2 trial was for 12 weeks and the phase trial was continued for an additional 40 weeks to assess how well the medication worked long-term. Studies showed that the medication was effective for controlling symptoms, though longer term studies evaluating the effects of the medication on quality of life, mood, and sexual well-being were suggested.
Potential Benefits
Vasomotor symptoms of menopause are believed to be associated with costs of about $2000 per person per year due to healthcare visits and missed work. They can also significantly impact quality of life, sleep, and sexual activity. Fezolinetant has the potential to improve both the quality of life and the economic costs associated with this distressing condition.
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Key Takeaways
- Fezolinetant is approved to treat vasomotor symptoms of menopause
- Fezolinetant may help improve menopause symptoms in people who are unable to take HRT due to their medical history
- Fezolinetant should not be taken by people with severe kidney disease or liver disease
- People on Fezolinetant should have their liver function tested prior to starting the medication and at 3, 6, and 9 months after starting the medication
- You should stop Fezolinetant and seek immediate medical attention if you develop signs or symptoms of liver dysfunction
- Tell your healthcare provider about all medications and health conditions prior to starting Fezolinetant
The FDA’s approval of Fezolinetant marks a significant milestone, and this first-in-class medication offers hope to many patients and innovation to the medical field. If you think this medication may be helpful for you, you should speak to your healthcare provider.
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