A new hot flash treatment is on the horizon! The FDA recently approved Veozah (Fezolinetant) for the treatment of hot flashes for women in menopause. This is the first drug treatment of its kind, and represents a viable option for those who are not able to receive hormone therapy.
Hot flashes are one of the most common symptoms of menopause, and can range from mild to severe. In the United States, 70-80% of women experience hot flashes during the menopause transition, and for many of them, they significantly impact their quality of life. “We have known that hormone replacement therapy (HRT) is an excellent treatment for hot flashes, however there are a subset of women who are not appropriate for HRT, or who choose not to use it,” says Dr. Rebecca Dunsmoor-Su, board-certified OB/GYN, and Gennev Chief Medical Officer. “Up until now, in these women we have used other medications such as anti-depressants with minimal to moderate reduction in hot flashes. With the approval of Veozah that changes today!”
According to the FDA statement, Veozah works by targeting and blocking a receptor in the brain which regulates body temperature.
Dr. Dunsmoor-Su shares, “To understand how it works it helps to know how the brain and ovary interact, and why menopause causes hot flashes (or temperature dysregulation). When we are having regular cycles there are neurons in the brain that release a pre-hormone called gonadotropin releasing hormone (GnRH) which stimulate the pituitary to talk with the ovary and develop one or more eggs for ovulation. This GnRH is released in a pulsing pattern, and different pulses signal different parts of the cycle. The pulses are regulated by feedback from the estrogen made by the ovary as it develops eggs. When the ovary runs out of eggs and does not respond to the pituitary, it does not release estrogen, which means the pulses go unregulated and are constant. The KNDY neuron connects this part of the hypothalamus to another part called the “warm sensing neuron”, which regulates what is a normal temperature range for your body. If the pulsing is constant, and constantly being transmitted to the warm sensing neuron, then the range of normal temperatures becomes very small, and any time you sense yourself to be outside that narrow range and you have a hot flash!”
Simply put, when a patient takes Veozah, it blocks one of the transmitters in the KNDY neuron, specifically neurokinin 3 (NK3), which means the body does not tell the warm sensing neuron about what is going on in the GnRH neuron, and the “normal” temperature range does not shrink. Thus, no hot flash is triggered.
Astellas Pharma US, Inc., the company that makes Veozah, did several large-scale studies which looked at effectiveness and safety to the drug. They reported that use of the medication reduced hot flashes by 50% or more over the 12 weeks of use compared to a placebo drug. Patients who continued the medication for a full 12 months saw continued benefits during that time. Because of the effectiveness of Veozah, they showed an improvement in quality of life due to hot flashes. There was also some noted improvement in sleep, though research was inconclusive to the drug’s impact on this symptom.
The most common side effect reported was headache. While there is no significant impact on the liver in the safety trials, because of previous concerns the FDA is recommending liver tests in the first year of use.
“Hormone therapy is still the best medicine for hot flashes,” says Dr. Dunsmoor-Su. “If you are not a good candidate for this medication, we are soon going to have a new medicine that is much more specifically targeting hot flashes with fewer side effects than our previous options. This is an exciting development and is going to be helpful for so many women who have not been able to find relief!”
Veozah is anticipated to be available for patients by early June. A potential downside? According to Astellas, a 30-day supply is expected to cost $550 a month.
Don’t let hot flashes negatively impact your quality of life. Visit with a Gennev doctor to address the role that hormonal shifts play in the symptoms you are experiencing, and access the treatments that are right for you.