Astellas Delivers Positive Phase III Results for Severe Menopausal Hot Flashes

 

Moderate to severe vasomotor symptoms (VMS), also known as hot flashes, have long been a problem by people facing menopause. This is characterized by a sudden warm feeling that is concentrated on the face, neck and chest, but can spread throughout the upper body. Usually, hot flashes cause excessive sweating and because of the lost body heat, the person may feel a rapid cooling afterward.

Astellas Pharma decided to study the potential of fezolinetant, a selective neurokinin-3 receptor (NK3R) antagonist, against hot flashes.

The series of double-blinded and placebo-controlled studies enrolled 1,028 women with moderate to severe VMS at 307 sites in the U.S., Canada and Europe. The researchers analyzed 30mg and 45mg fezolinetant administered once-daily for 12 weeks. It was followed by 40-week active treatment extension periods.

The results of the studies show a statistically significant reduction from the baseline in both the frequency and severity of moderate to severe VMS. This reduction was observed in Week 4 to Week 12 among women who took 30 to 45 mg of fezolinetant once a day.

The fezolinetant is a selective antagonist that binds on the kisspeptin/neurokinin/dynorphin (KNDy) neuron to moderate neuronal activity in the thermoregulatory center in the hypothalamus of the brain to treat VMS associated with menopause.

If fezolinetant is approved by the U.S. Food and Drug Administration (FDA), it will become the first non-hormonal treatment that is aimed to reduce both the frequency and severity of VMS in connection to menopause.

VMS is the most common symptom associated with menopause, affecting more than 50% of women 40 to 64 years of age. Patients with VMS often report that the hot flashes have a negative impact on their energy and mood levels, and even on their productivity and relationships.

Traditionally, hot flashes are treated using hormones in the form of oral or transdermal estrogen. This hormone therapy consists of estrogen alone or combined with progesterone. Past research suggests that estrogen hormone therapy (HT) can reduce the frequency and severity of hot flashes.

What is unfortunate about this therapy is that a National Institute for Health (NIH)-sponsored study showed that HT increases the risk of heart attack, breast cancer and stroke among the menopausal women in the study. More so, another study shows that HT is not as effective among older women and may only show positive effects among younger women.

These caveats of HT have inspired pharmaceutical companies to find an alternative solution to VMS.