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Is FDA-approved Veozah a game-changer in menopause hot flash treatment?

Kevin Pho, MD
KevinMD
May 12, 2023
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The medical world is buzzing following the FDA’s green light for Veozah. This is a one-of-a-kind, non-hormonal drug designed to tackle hot flashes in menopausal women. It brings fresh hope to countless women in the U.S. who’ve been grappling with these troublesome symptoms.

Around 80 percent of menopausal women suffer from hot flashes, which bring sudden spells of sweating, flushing, and chills. This unpleasant condition is caused by a glitch in the hypothalamus’s temperature regulation center, governed by neurons named neurokinin 3 receptors (NK3 receptors). Estrogen usually keeps these receptors in check, but during menopause, estrogen levels plunge, causing the NK3 neurons to go into overdrive and disrupt body temperature.

Enter Veozah, also known as fezolinetant, the pioneer non-hormonal drug sanctioned by the FDA to treat moderate to severe hot flashes in menopausal women. It works by latching onto these hyperactive NK3 receptors in the brain, pacifying the neurons that spark off hot flashes, and effectively stepping into estrogen’s shoes in temperature control. Clinical trials indicate that Veozah cuts down the frequency and intensity of hot flashes significantly more than a placebo. Moreover, its effectiveness was maintained over a year-long research period, suggesting it could offer lasting benefits.

These trials also demonstrated that Veozah is safe, with a notable decrease in the frequency and severity of hot flashes. It also helped with sleep problems linked to menopausal symptoms. While some participants reported minor side effects such as headaches, nausea, and tiredness, the trials didn’t flag any serious adverse effects.

Veozah provides an alternative solution for women who cannot or do not wish to take hormone therapy. However, it’s worth highlighting the potential advantages of estrogen. Hormone therapy has shown its effectiveness in easing hot flashes and providing lasting health benefits, including improved bone density, heart health, mood, and sexual health. Estrogen is still considered the best choice for relieving menopausal symptoms, particularly if started early in perimenopause and post-menopause phases. It’s crucial to consider an individual’s health history and potential risks linked with hormone therapy when deciding on a treatment plan.

Veozah’s approval is a glimmer of hope for women struggling with menopausal hot flashes. Yet, its price tag—$550 for a month’s supply as set by the maker, Astellas Pharma—is a serious consideration. To help with affordability, Astellas Pharma has introduced a support program.

The Institute for Clinical and Economic Review suggests a lower yearly price range of $2,000 to $2,600 for Veozah, given its effectiveness and potential to improve quality of life. Future price adjustments may be on the cards to make this innovative treatment more accessible.

While Veozah has shown potential in reducing hot flashes and improving sleep quality, some areas still require further investigation. The impacts on heart health, bone health, sexual health, mood symptoms, and weight are yet to be fully explored. These factors can only be fully evaluated once the drug is used by a larger population over a longer period. Continuous research and real-world data are essential to grasp the wider impact and potential long-term benefits of Veozah.

Veozah’s approval by the FDA marks a significant breakthrough in treating menopausal hot flashes. This non-hormonal drug presents a new, effective option for women who are unable or unwilling to undergo hormone therapy. Despite Veozah’s promising results in reducing hot flashes and enhancing sleep quality, it’s crucial for women to discussing their options with their clinicians. A joint decision, based on each woman’s unique health history and circumstances, is necessary to determine the best treatment course.

Veozah’s endorsement by the FDA is a significant step forward in addressing menopausal symptoms. This novel treatment option brings a ray of hope to millions of women who battle with these often disruptive symptoms daily. While the future of Veozah looks bright, we need more research to fully understand its long-term impacts.

With Veozah’s entry into the market, women have a broader range of options for managing their menopausal symptoms. The potential this medication holds to improve many women’s quality of life makes it a landmark development in women’s health. But as always, with new treatments comes the need for caution and consultation with a trusted clinician to navigate these options safely and effectively.

Veozah’s launch signals a new dawn in the treatment of menopausal symptoms. It provides an alternative for those who might not be suitable for or choose not to use hormone therapy. While this is an exciting development, it also serves as a reminder of the importance of personalized patient care. It underlines the need to consider each woman’s unique health history, lifestyle, and preferences when creating a treatment plan. As we continue to learn more about Veozah, it’s hopeful that this drug will be a valuable addition to the array of treatments for menopausal symptoms.

Kevin Pho is an internal medicine physician and founder, KevinMD.

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