Real-World Data Shows Fezonatant Improves VMS, Sleep, and Work Productivity in Women with Diagnosed Menopausal VMS

The OPTION-VMS analysis included more than 900 women aged 40-75 years diagnosed with menopausal VMS who received non-hormonal therapies (non-HT) to treat bothersome VMS: fezolinetant, selective serotonin reuptake inhibitor/selective serotonin reuptake inhibitor, gabapentin, oxybutynin. Women treated with fezonatant met the study's primary endpoint at week 12 and showed statistically significant improvements at earlier time points (weeks 4 and 8). 1

Fezolinent treatment results in:

Statistically significant reductions in VMS distress, as measured by the Menopause-Specific Quality of Life (MENQOL) VMS domain, were observed at Week 12 (primary endpoint) and at Weeks 4 and 8 (secondary endpoints).

Statistically significant improvements were seen in MENQOL T total scores and cross-domain categories (sexual, psychosocial and physical) at weeks 4, 8 and 12.

At all three time points, patient-reported sleep disturbances were significantly reduced, as reflected inPROMIS SD SF 8b total T-score.

Objective improvements in sleep via actigraphy, including reductions in awakenings after sleep onset (WASO) at weeks 4, 8, and 12 and increased sleep efficiency at weeks 4 and 12.

According to Astellas Pharmaceuticals, the drug's developer, the incidence of treatment adverse events related to fezonetant is low. This characterization was consistent with previous clinical trial and post-marketing data, and no new safety signals were identified.

Patient-reported sleep quality and quality of life scores also improved significantly in women takingSSRIs/SNRIs or other non-HT medications such as gabapentin or oxybutynin. However, in the SSRI/SNRI group, no statistically significant improvements in objective sleep measures (WASO, sleep efficiency, or sleep latency) were observed, whereas in the other non-HT groups, WASO improved significantly at all time points.

Another preliminary analysis from the same study showed that use of filazonatant was associated with statistically significant improvements in the VMS-specific Work Productivity and Activity Impairment Questionnaire (WPAI-VMS). Improvements were seen in areas such as impaired activity, reduced overall productivity and presenteeism. Statistically significant improvements were also reported in the SSRI/SNRI and other non-HT treatment groups.

By 2030With 1.2 billion women expected to be perimenopausal or postmenopausal by 2030, and millions more experiencing symptoms that may impact their health and working lives, it is more important than ever to address the burden of menopause. Menopausal symptoms can significantly impact a woman’s quality of life and financial stability. About one-third of working women report that they struggle to cope at work due to menopause-related symptoms, with severe symptoms prompting women to consider changing careers, reducing their hours, or leaving the workforce entirely.

These new preliminary findings reinforce Astellas's commitment to advancing our understanding of felazonatant beyond pivotal clinical trials, with the goal of making a meaningful difference to those affected by VMS. The ongoing OPTION-VMS study (NCT06049797) is enrolling 998 women at 50 sites in the United States. Its primary aim was to assess changes in VMS distress in women receiving non-hormonal treatments in a real-world setting, with secondary outcomes assessing sleep, sexual health, mood, work productivity and safety.

According to Astellas, fezonatant is suitable for the treatment of moderate to severe vasomotor symptoms caused by menopause. Its mechanism of action is to block the combination of neurokinin B and hypothalamic KNDy neurons to reduce the frequency and intensity of heat flashes.

References:https://www.patientcareonline.com/view/topline-real-world-data-show-fezolinetant-improves-vms-sleep-and-work-productivity-in-women-with-confirmed-menopausal-vms