The US Food and Drug Administration (FDA) has granted approval to elinzanetant, a new once-a-day, hormone-free pill intended to relieve moderate to severe hot flashes in menopause women. This medication will be available starting in November under the brand name Lynkuet, according to the pharmaceutical company Bayer.

A phase 3 clinical trial, which included 628 postmenopausal women, showed that elinzanetant reduced the frequency of vasomotor symptoms by more than 73%, compared to a 47% reduction reported by the placebo group. The most common side effects include drowsiness, fatigue, and headaches.

With more than 80% of women experiencing hot flashes during menopause, the need for effective treatment options for those who cannot opt ??for hormonal therapies due to health conditions is emphasized. Experts say the new drug offers significant relief, particularly for those dealing with the impact of hot flashes on their daily lives, CNN reports.

Expert Comments

Bayer's Christine Roth said the approval represents an important step forward in addressing the individual needs of women going through menopause.

Claire Gill, president of the National Menopause Foundation, also stressed the importance of providing more treatment options for these conditions. The new treatment follows the recent approval of fezolinetant, another non-hormonal alternative.

Hot Flashes During Menopause

Hot flashes are the most common symptom of menopause, affecting approximately three in four women. They feel like a sudden sensation of heat in the upper body, especially the face, neck and chest, accompanied by redness, intense sweating and, in some cases, chills after the episode.

These can last between 30 seconds and 5 minutes, and their frequency and intensity vary between women, and can persist from the year before to even 14 years after menopause.

Hot flashes occur primarily due to changes in hormone levels, especially the decrease in estrogen, which affects the body's thermostat located in the hypothalamus, making it more sensitive to small temperature changes.This triggers a reaction to cool the body, which manifests as hot flashes and sweating. Hot flashes at night can affect your sleep and quality of life, so it's important to see a healthcare professional if they are severe or persistent.

Hormonal Treatments

Hormonal treatments for menopause, known as hormone therapy or hormone replacement therapy (HRT), are used to replace the estrogen that the body stops producing after menopause. This can help relieve symptoms such as hot flashes and vaginal dryness and prevent bone loss (osteoporosis).

There are two main types of hormone therapy:

If your uterus is preserved, estrogen is usually combined with a progestogen to avoid the risk of endometrial cancer that estrogen alone can cause. This combination therapy can be continuous or cyclical, depending on the regimen prescribed by your doctor.

Other related treatments include tibolone, which has estrogenic, progestogenic, and androgenic effects, but its use depends on a medical evaluation.

How to Determine if Non-Hormonal Treatment is Right for You

Menopausal women can determine if elinzanetant is right for them by considering several important aspects related to their symptoms, medical history, and personal preferences.

Elinzanetant is a non-hormonal medication approved to treat moderate to severe vasomotor symptoms of menopause, primarily hot flashes and night sweats. It is especially indicated for women who cannot or prefer not to use hormone therapy because of medical contraindications or a history of cancer.

Clinical Considerations: