Veozah (Fezolinetant): A Non-Hormonal Treatment for Menopausal Vasomotor Symptoms
Veozah (fezolinetant) is a first-in-class, non-hormonal neurokinin 3 receptor (NK3R) antagonist approved by the FDA in May 2023 for treating moderate to severe vasomotor symptoms (hot flashes and night sweats) associated with menopause.
Mechanism of Action
- Works by blocking NK3 receptors in the brain's thermoregulatory center
- Inhibits NK3R-mediated signaling in the central nervous system to modulate neurons associated with thermoregulation
- Provides a non-hormonal alternative for women who cannot or prefer not to take hormone therapy
Clinical Efficacy
- Demonstrated significant reduction in both frequency and severity of vasomotor symptoms in phase 3 clinical trials 1
- Improvements observed as early as 1 week after starting treatment
- Maintains effectiveness over 52 weeks of treatment
- Reduces hot flash frequency by approximately 2-2.5 episodes per day compared to placebo at 12 weeks
Dosing and Administration
- Recommended dose: 45 mg tablet taken once daily
- Oral formulation with proportional pharmacokinetics 2
- Can be taken with or without food
Safety Profile
Most common adverse effects are generally mild 1, 2:
- Headache
- Abdominal pain
- Diarrhea
- Insomnia
- Back pain
- Hot flush
Liver monitoring is recommended due to potential for liver enzyme elevations, though these are typically:
- Asymptomatic
- Transient
- Resolve during treatment or after discontinuation
Patient Selection and Considerations
Appropriate for women experiencing moderate to severe vasomotor symptoms of menopause
Particularly valuable for women who:
- Have contraindications to hormone therapy
- Prefer non-hormonal treatment options
- Experience inadequate relief with other therapies
Not recommended for women who:
- Are pregnant or planning pregnancy
- Have severe liver impairment
Clinical Implications
- Addresses an important unmet need for non-hormonal management of menopausal symptoms
- May improve quality of life by reducing the frequency and severity of hot flashes and night sweats
- Represents a significant advance in menopausal symptom management beyond traditional hormone therapy
Monitoring Recommendations
- Baseline liver function tests before initiating therapy
- Periodic liver function monitoring during treatment
- Assessment of symptom improvement at follow-up visits
Veozah represents an important advancement in the management of menopausal vasomotor symptoms, offering an effective non-hormonal option with a favorable safety profile for women seeking relief from hot flashes and night sweats.