Menopause is a natural biological process that marks the end of a woman’s reproductive years and it typically occurs in women between the ages of 45 and 55, although it can happen earlier or later where one common symptom associated with menopause is hot flashes, also known as hot flushes. Hot flashes are sudden feelings of warmth, often accompanied by redness and sweating, that primarily affect the upper body.
They can range in intensity and duration, lasting from a few seconds to several minutes and are caused by hormonal changes, specifically a decrease in estrogen levels, which can disrupt the body’s temperature regulation. In some cases, hormone replacement therapy (HRT) may be recommended by a healthcare professional to alleviate menopausal symptoms, including hot flashes but is it crucial to discuss the risks and benefits of HRT with your doctor to determine if it is appropriate for you.
What is this fezolinetant drug?
Fortunately for some, the US Food and Drug Administration on May 12 this year, approved Veozah (fezolinetant), an oral medication for the treatment of moderate to severe vasomotor symptoms or hot flashes, caused by menopause. The FDA claimed that Veozah is the first neurokinin 3 (NK3) receptor antagonist approved by it to treat moderate to severe hot flashes from menopause where it works by binding to and blocking the activities of the NK3 receptor, which plays a role in the brain’s regulation of body temperature.
Licensed in the US, the drug fezolinetant could be approved for use in the UK by the end of the year. In an interview with The Guardian, Prof Waljit Dhillo, an endocrinologist at Imperial College London who led a pioneering trial in 2017 that paved the way for the drug’s development, shared, “This is going to be a completely blockbuster drug. It’s like a switch. Within a day or two the flushes go away. It’s unbelievable how well these drugs work. It’s going to be completely gamechanging for a lot of women.”
He added, “From our grant being awarded by NIHR [the National Institute for Health and Care Research] and MRC [the Medical Research Council], within two years we could show it had a 73% reduction in hot flushes – that wouldn’t have happened without taxpayers’ funding of medical research. Since doing our studies, we’ve had women all over the world writing to us saying: ‘How can I get this drug?’ There’s been this attitude that obesity kills, heart disease kills, diabetes kills, women’s health doesn’t kill. We can’t be in a western society and say 51% of the population’s problems – if they don’t kill them immediately – aren’t important.”
Prof Richard Anderson, Co-Director of the Centre for Reproductive Health at the University of Edinburgh, gushed, “What’s really amazing about these drugs is how quickly they work and how big an effect they have. Typically, oestrogen takes several weeks to have an effect. With these, women are reporting effects from the first tablet.”
Adding to the list of leading doctors rooting for the drug, US neuropathologist Prof Naomi Rance, who identified a specific group of neurons that become enlarged in the brains of menopausal women, revealed, “I realised that understanding the brain circuitry controlling hot flushes could be useful for designing new treatments but I never imagined that it would happen during my life. I was thrilled to learn about the FDA approval, in part because it illustrates how basic science research can lead to clinical applications.”
Challenges of taking fezolinetant:
While the drug is currently being assessed by the European Medicines Agency (EMA), it is important to note that the prescribing information for Veozah includes a warning for elevated hepatic transaminase or liver injury. The FDA had cautioned that before using Veozah, patients should have blood work done to test for liver damage and while on Veozah, routine bloodwork should be performed every three months for the first nine months of using the medication.
The report by FDA had stated, “Patients experiencing symptoms related to liver damage—such as nausea, vomiting, or yellowing of the skin and eyes—should contact a physician. Veozah cannot be used with CYP1A2 inhibitors. Patients with known cirrhosis, severe renal damage or end-stage renal disease should not take Veozah. The most common side effects of Veozah include abdominal pain, diarrhea, insomnia, back pain, hot flush and elevated hepatic transaminases.”