Breakthrough Menopause Drug Approved by FDA

Medicine for woman. Concept of menopause, premenstrual syndrome, menstruation or estrogen. Female health. | Image by baon, Shutterstock

A new breakthrough drug aiming to reduce the symptoms of menopause was approved by the U.S. Food and Drug Administration (FDA) last week.

Veozah was developed by Astellas Pharma to target the root cause of the hot flashes and night sweats frequently experienced by women once they enter menopause. The FDA’s approval on May 12 will green-light a revolutionary treatment for those suffering from these disruptive events.

Menopause itself has three phases, according to the Cleveland Clinic.

Perimenopause is a hormonal transitory phase in a woman’s life that typically starts during her mid-to-late 40s. The body begins to produce less estrogen and progesterone, hormones that are key to the female reproductive system.

Menopause usually occurs around age 51 when menses stop. Once a woman goes 12 straight months without having a period, she is considered in the post-menopause phase. It is at this time that most women start to experience fewer menopausal symptoms.

This means some women might experience menopausal symptoms for as many as 10 years.

Menopausal symptoms include irregular periods, sleep disruptions, mood swings, weight gain, and hot flashes — the latter being the most prevalent.

Hot flashes can be triggered by hot weather, drinking alcohol, wearing tight clothes, or stress.

Being overweight or obese substantially increases the risk of experiencing hot flashes, as research has shown. As The Dallas Express reported, Texas currently has an adult obesity rate of 35.9%, higher than the national average of 33.7%.

Astellas developed Veozah to help minimize the hot flashes experienced by approximately 60% to 80% of women during menopause, according to its press release.

Menopausal symptoms are typically managed by either hormonal replacement therapy or certain antidepressants. Both of these come with certain risks, including a heightened risk of cancer or stroke in the case of the former and low energy, nausea, and weight gain in the case of the latter.

Veozah, also referred to as fezolinetant, thus represents a groundbreaking advancement in the treatment of hot flashes.

As explained by Genevieve Neal-Perry, who is the chair of the UNC School of Medicine Department of Obstetrics and Gynecology, “This therapy is based on our understanding of the biology behind hot flashes,” according to the Veozah press release.

Essentially, menopause disrupts the balance that used to exist between estrogen and neurokinin B (NKB), a brain chemical responsible for managing body temperature.

Veozah blocks NKB, thereby restoring balance and allowing the body to maintain a normal temperature without these high spikes.

Astellas conducted two phase-three clinical trials in both the U.S. and Canada while testing out this treatment option.

More than 3,000 menopausal women were given either Veozah or a placebo and observed over 52 weeks, according to the FDA. The results were highly promising, as Veozah significantly reduced the frequency of weekly hot flashes experienced by the trial participants.

Some side effects were reported, including back pain, stomach pain, and insomnia. Those with liver disease or issues related to liver function are not advised to take this drug, according to the FDA.

The recommended dosage of Veozah is a once-daily pill of 45 milligrams taken orally at a regular time, with one month’s supply priced at $550.

The monthly cost of hormonal replacement therapy drugs ranges from $130 to $240.

With Veozah placed at a premium, many women might still turn to hormonal replacement therapy as a more cost-effective option, as Dr. Stephanie Faubion, who leads the Mayo Clinic’s Center for Women’s Health, told CNN.

Nevertheless, Faubion pointed out the importance of having multiple alternatives available to women.

“I think at the end of the day, it’s always good that women have more options, so I’m happy to see that there’s been further development in an overlooked field, and that is menopausal medicine,” Faubion explained, noting that further research needs to be done on Veozah and similar drug treatments.

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