Veozah™ -- the First Non-Hormonal Medication Now Approved to Treat Moderate to Severe Hot Flashes Caused by Menopause
In May 2023, the U.S. Food and Drug Administration (FDA) approved Veozah (fezolinetant), marking a significant milestone in women's health. Veozah is the first non-hormonal prescription medication specifically approved to treat moderate to severe vasomotor symptoms -- commonly known as hot flashes -- caused by menopause. This approval offers a new option for the millions of women who experience these disruptive symptoms but cannot or prefer not to use hormone-based therapies.
What is Veozah?
Veozah (fezolinetant) is a neurokinin 3 (NK3) receptor antagonist. It works by blocking NK3 receptors in the thermoregulatory center of the brain, specifically in the hypothalamus. During menopause, declining estrogen levels cause certain neurons called KNDy (kisspeptin/neurokinin B/dynorphin) neurons to become overactive. This overactivity disrupts the body's internal thermostat, leading to hot flashes. By blocking the NK3 receptor, Veozah helps restore normal thermoregulation without affecting hormone levels.
How Does It Differ from Hormonal Treatments?
Traditionally, hormone replacement therapy (HRT) has been the standard treatment for menopausal hot flashes. While effective, HRT is not suitable for all women. Those with a history of breast cancer, blood clots, stroke, or liver disease may be advised against hormonal therapies. Additionally, some women simply prefer to avoid hormone-based treatments due to personal concerns about potential risks.
Veozah provides a fundamentally different approach. Rather than replacing hormones, it targets the neurological pathway that triggers hot flashes. This mechanism makes it a viable option for women who have contraindications to HRT or who are seeking an alternative.
Clinical Trial Results
The FDA approval of Veozah was based on the results of two pivotal Phase 3 clinical trials, known as SKYLIGHT 1 and SKYLIGHT 2. These studies enrolled over 1,000 postmenopausal women experiencing moderate to severe hot flashes. Key findings included:
- Significant reduction in the frequency of moderate to severe hot flashes compared to placebo, observed as early as the first week of treatment.
- Meaningful reduction in the severity of hot flashes over the 12-week treatment period.
- Sustained benefits observed through 52 weeks in the long-term extension studies.
The most commonly reported side effects in clinical trials included abdominal pain, diarrhea, insomnia, back pain, and hot flush (a transient increase before improvement). The FDA labeling also includes monitoring recommendations for liver function, as elevated liver enzymes were observed in some participants.
Who May Benefit from Veozah?
Veozah may be particularly beneficial for:
- Women experiencing moderate to severe hot flashes who cannot take hormone therapy due to medical contraindications.
- Women who have tried hormonal treatments but experienced unacceptable side effects.
- Women who prefer a non-hormonal approach to managing menopausal symptoms.
- Breast cancer survivors and others for whom estrogen-based therapies are not recommended.
Dosage and Administration
Veozah is taken as a once-daily oral tablet at a dose of 45 mg. It can be taken with or without food. Before starting Veozah, and periodically during treatment, healthcare providers may order blood tests to monitor liver function.
The Broader Impact
The approval of Veozah represents more than just a new medication; it signals a shift in how we approach menopause management. For decades, the options for treating hot flashes have been limited, and many women have suffered in silence. The development of a targeted, non-hormonal therapy validates the experience of menopausal women and acknowledges the need for diverse treatment options.
As clinical research continues to explore new approaches to menopausal symptom management, Veozah serves as a promising example of how innovative science can improve quality of life. If you are experiencing moderate to severe hot flashes, talk to your healthcare provider to determine whether Veozah may be right for you.