Phase 3b study: Fezolinetant safe, effective for vasomotor symptoms

Article

Astellas has announced positive results of a trial evaluating the safety and efficacy of fezolinetant in menopausal women with moderate to severe vasomotor symptoms.

Phase 3b study: Fezolinetant safe, effective for vasomotor symptoms | Image Credit: © Egor - © Egor - stock.adobe.com.

Phase 3b study: Fezolinetant safe, effective for vasomotor symptoms | Image Credit: © Egor - © Egor - stock.adobe.com.

Fezolinetant (VEOZAH; Astellas Pharma Inc) has shown positive results in a phase 3b DAYLIGHT (NCT05033886) clinical trial measuring safety and efficacy against moderate to severe vasomotor symptoms (VMS) in menopausal women.

The DAYLIGHT study was conducted to determine the safety and efficacy of fezolinetant for treating moderate to severe VMS where hormone therapy is not recommended in menopausal women aged 40 to 65 years. VMS is a common condition of menopause, with symptoms including hot flashes and night sweats.

Fezolinetant is an FDA approved nonhormonal treatment option for treating moderate to severe VMS. It is a neurokinin 3 and improves symptoms through regulating neuronal activity in the hypothalamus. This is accomplished by blocking neurokinin B binding on the kisspeptin/neurokinin B/dynorphin neuron.

There were 450 women recruited for the DAYLIGHT study across 69 different sites located in Turkey, Canada, and Europe. Over a 24-week period, participants received either fezolinetant 45 mg or placebo once per day. 

The primary outcome of the study was a reduction in moderate to severe VMS from baseline to week 24. Less than 5% of patients experienced serious treatment-emergent adverse events (TEAs), with common TAEs including headache and COVID-19.

Fezolinetant should not be taken by patients with a severe kidney condition or kidney failure, cirrhosis, or taking CYP1A2 inhibitors. Potential severe side effects include increased liver blood test problems. Liver problems present through vomiting, nausea, jaundice, and abdomen pain. Other adverse events include insomnia, back pain, hot flashes, and diarrhea.

Fezolinetant was previously evaluated in the BRIGHT SKY pivotal trials, SKYLIGHT 1 (NCT04003155) and SKYLIGHT 2 (NCT04003142). There were over 1000 participants with moderate to severe VMS in these trials, which included 12 weeks of placebo-controlled treatment followed by a 40-week treatment extension period.

Overall, studies have indicated positive safety and efficacy for fezolinetant against moderate to severe VMS.Astellas has projected an impact from the DAYLIGHT study’s results to be seen before the end of the current fiscal year.

Reference

Phase 3b trial of fezolinetantshows positive topline results for treatment of VMS due to menopause. Astellas. June 27, 2023. Accessed June 28, 2023. https://newsroom.astellas.us/2023-06-27-Phase-3b-Trial-of-Fezolinetant-Shows-Positive-Topline-Results-for-Treatment-of-VMS-Due-to-Menopause

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