New Non-Hormonal Drug Elinzanetant Shows Promise in Reducing Menopausal Hot Flashes

August 22, 2024
New Non-Hormonal Drug Elinzanetant Shows Promise in Reducing Menopausal Hot Flashes
  • The need for effective nonhormonal alternatives is critical, especially for women who cannot tolerate hormone therapy due to health concerns or personal choice.

  • Further research is necessary to evaluate the long-term safety and efficacy of elinzanetant beyond the initial treatment period.

  • Recent research published in the Journal of the American Medical Association details two phase 3 trials, known as Oasis 1 and 2, which evaluated the investigational nonhormonal drug elinzanetant for treating hot flashes in postmenopausal women.

  • The trials involved approximately 796 women aged 40 to 65 who experienced moderate to severe vasomotor symptoms, with participants receiving either 120 mg of elinzanetant or a placebo daily for 12 weeks, followed by an additional 14 weeks of elinzanetant for all.

  • Elinzanetant has been shown to significantly reduce the frequency and severity of hot flashes while also improving sleep quality and overall quality of life.

  • Results indicated statistically significant improvements in hot flash frequency and severity within the first week of treatment, with continued enhancements noted by week 12.

  • The drug also positively impacted sleep disturbances and menopause-related quality of life, demonstrating a favorable safety profile with common mild side effects such as headaches and fatigue.

  • No severe side effects were reported during the trials, highlighting elinzanetant's tolerability among participants.

  • Hormone therapy has traditionally been the primary treatment for hot flashes, but its use has declined due to concerns over potential health risks.

  • Limitations of the trials include their focus on postmenopausal individuals and reliance on patient-reported outcomes, which may introduce bias.

  • Bayer has submitted the study data to the FDA for approval, marking a significant step towards making elinzanetant available to women suffering from hot flashes.

  • Hot flashes, or vasomotor symptoms, are caused by decreased estrogen levels during menopause and can lead to discomfort and other health issues, emphasizing the importance of effective treatments.

Summary based on 5 sources


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