Safety and efficacy of fezolinetant proven in Hispanic women

In an interview with Contemporary OB/GYN, Genevieve Neal-Perry, MD, PhD, professor and chair at the UNC School of Medicine Department of Obstetrics and Gynecology, discussed the findings from a study focused on the burden of hot flashes in Hispanic women and the effectiveness of fezolinetant, a non-hormonal treatment.

How flashes have been linked to increased risks of heart disease, Alzheimer’s, and cognitive dysfunction in Hispanic patients, making management vital. Additionally, many Hispanic individuals have medical conditions that make them ineligible for menopausal hormonal therapy, highlighting the need for safe, alternative treatments.

The study analyzed pooled data from the SKYLIGHT 1, 2, and 4 trials to determine the burden of hot flashes and any adverse effects associated with the treatment. The trials involved approximately 350 participants, with 70 to 80 identifying as Hispanic. The researchers controlled for variables such as age, body mass index (BMI), smoking habits, and whether the participants had undergone a hysterectomy, all of which could impact menopausal experiences.

Fezolinetant, the drug studied, is an NK3 receptor antagonist, targeting neurons in the brain that trigger hot flashes. The drug blocks the activity of specific neurons that communicate with those responsible for hot flashes. The study examined the drug's effectiveness 45 mg and 30 mg dose, with the FDA-approved 45 mg dose significantly reducing both the frequency and severity of hot flashes in Hispanic participants. The 30 mg dose also showed positive results, though not as pronounced.

One of the key takeaways is that fezolinetant was highly effective in treating hot flashes in Hispanic individuals. Furthermore, the group experienced fewer adverse effects, such as headaches and gastrointestinal discomfort, compared to others. These findings are significant, especially for individuals who cannot use hormone replacement therapy because of existing medical conditions, offering a safe and effective alternative.

The study underscores the importance of having diverse treatment options for managing menopausal symptoms, particularly for marginalized groups who are often underserved by existing therapies. Fezolinetant provides a promising non-hormonal option for these individuals, improving both the frequency and severity of hot flashes while maintaining a favorable safety profile.