BACKGROUND AND PURPOSE:

• Newer nonhormonal medications are being investigated for the treatment of vasomotor symptoms (VMS) and sleep symptoms associated with menopause
• Elinzanetant is a selective NK-1,3 receptor antagonist that may improve sleep and quality of life for women with menopause
• Simon et al. (Menopause, 2023) sought to determine the efficacy and safety of elinzanetant for improving menopause symptoms

METHODS:

• Phase 2b, adaptive, dose-range finding study
• Multicenter, multicountry, double-blind, placebo-controlled
  • 25 sites across the US, UK, and Canada
• Participants
  • Postmenopausal women
  • 40 to 65 years
  • ≥7 moderate-to-severe VMS per day
• Intervention
  • Elinzanetant at 40 mg, 80 mg, 120 mg, or 160 mg once daily
  • Placebo once daily
• Primary outcomes
  • A reduction in mean frequency and severity of moderate-to-severe VMS at weeks 4 to 12
• Secondary outcomes
  • Patient-reported assessments of sleep and quality of life

RESULTS:

• 180 participants
• Compared to placebo, elinzanetant 120 mg and 160 mg achieved reductions in VMS frequency
  • 120 mg at week 4: difference in least squares (LS) means −3.93 (SE, 1.02) | P<0.001
  • 120 mg at week 12: difference in LS means −2.95 (SE, 1.15) | P=0.01
  • 160 mg at week 4:  difference in LS means −2.63 (SE, 1.03) | P=0.01
• Elinzanetant 120 mg reduced nighttime awakenings at weeks 1, 2, 4, and 8 (P = 0.006 to P = 0.049), but not at week 12
  • Elinzanetant 160 mg did not improve sleep compared to placebo
• Both 120 mg and 160 mg doses improve quality of life at 4 and 12 weeks
  • 120 mg at week 4: difference in LS means −3.41 (SE, 0.92) | P<0.001
  • 120 mg at week 12: difference in LS means −4.27 (SE, 1.01) | P<0.001
  • 160 mg at week 4: difference in LS means −3.28 (SE, 0.95) | P<0.001
  • 160 mg at week 12: difference in LS means −4.85 (SE, 1.05) | P<0.001
• All doses were well tolerated

CONCLUSION:

• Elinzanetant at 120 mg or 160 mg daily reduced VMS frequency through 4 to 12 weeks vs placebo
• The authors state

…the 120-mg dose offers clinically important efficacy across a range of menopause-related symptoms with the most favorable benefit/risk profile

The efficacy and safety of elinzanetant 120 mg will be further evaluated in a phase 3 program

Learn More – Primary Sources:

Efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist for vasomotor symptoms: a dose-finding clinical trial (SWITCH-1)