Fezolinetant for Hot Flashes

(FAVES-B Trial)

This trial tests a drug called fezolinetant to determine its effects on heart and brain health in women experiencing moderate to severe menopausal hot flashes and night sweats. Participants will take either fezolinetant or a placebo (a pill with no active medicine) for 12 weeks to assess the drug's effectiveness compared to no treatment. Ideal participants are women who have frequently experienced intense hot flashes and seek relief. The study will include regular checkups and tests to monitor health changes. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

You may need to stop taking certain medications to join this trial. Specifically, you cannot use treatments for hot flashes, systemic sex-hormone medications, cytochrome P450 1A2 inhibitors, or cardiovascular medications.

Research has shown that fezolinetant is generally safe for most women experiencing menopausal hot flashes and night sweats. In a study with 1,830 participants, the treatment proved safe over a year. Most participants tolerated the drug well, though some experienced side effects, such as liver problems, which were rare. Another study found that about 39% of participants had side effects, but these were usually mild. Overall, fezolinetant appears promising as a non-hormonal treatment, but awareness of the rare yet serious liver risks is important.¹²³⁴⁵

Unlike other treatments for hot flashes, which often involve hormone replacement therapy, fezolinetant operates differently by targeting the neurokinin B receptor. This approach is exciting because it potentially reduces symptoms without the hormonal side effects associated with current treatments. Fezolinetant offers a non-hormonal option, which is particularly important for those who cannot or prefer not to use hormone-based therapies.

Research has shown that fezolinetant, the active study drug in this trial, can significantly reduce hot flashes and night sweats in menopausal women. Studies have found that taking 45 mg of fezolinetant once daily can decrease the number and intensity of these symptoms by about 60% in 12 weeks. It outperforms other non-hormonal treatments in reducing moderate to severe hot flashes and night sweats. Additionally, fezolinetant is generally safe, allowing most people to use it without serious side effects. Overall, it appears to be an effective option for managing menopausal symptoms.³⁶⁷⁸⁹