A drug to treat hot flashes caused by the menopause has been approved by the Food and Drug Administration (FDA).
The non-hormonal drug fezolinetant, sold under the brand name Veozah and developed by Japanese drugmaker Astella Pharma, will now be available via prescription to women across the US.
A number of supplements and hormones on the market exist to give relief from menopausal hot flashes, but the new drug targets the cause of the hot flashes.
More than one million American women start ‘the transition’ every year, which researchers also revealed costs US employers at least $27 billion annually through sick days and healthcare expenses.
Roughly 80 percent of menopausal women get hot flashes, which can include periods of sweating, flushing and chills lasting several minutes
The drug treats moderate to severe vasomotor symptoms, such as hot flashes and night sweats.
Veozah, with the active ingredient of fezolinetant, is designed to block a chemical that modulates nerve cell activity in the part of the brain that regulates body temperature.
Dr Janet Maynard, director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research, said: ‘Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life.
‘The introduction of a new molecule to treat moderate to severe menopausal hot flashes will provide an additional safe and effective treatment option for women.’
Menopause occurs when a woman’s periods stop permanently, marked by the point when a woman hasn’t had one for 12 months in a row.
During menopause, women slowly produce less of the hormones estrogen and progesterone.
It usually happens between the ages of 45 and 55, with 51 being the US and UK average.
More than one million American women start ‘the transition’ every year, which can cause a host of debilitating symptoms, from hot flashes, a dry vagina to even low self-esteem.
Roughly 80 percent of menopausal women get hot flashes, which can include periods of sweating, flushing and chills lasting several minutes.
A hot flash occurs due to a drop in estrogen levels, which leads your glands to release greater amounts of other hormones which impact the body’s thermostat, causing sharp rises in temperature.
Some women who are affected by hot flashes as well as vaginal bleeding, stroke, heart attack, blood clots or liver disease cannot have hormonal therapies.
Veozah is not a hormone and instead targets the brain activity which causes hot flashes during menopause.
One 45milligram pill should be swallowed once a day with or without food, at the same time every day.
The most common side effects of Veozah are abdominal pain, diarrhea, insomnia, back pain, hot flush and elevated hepatic transaminases.
Prescribing information includes a warning for elevated hepatic transaminase, or liver injury.
Before taking the medication, women should have a blood test to check for liver damage or infection.
While taking it, patients should have blood tests done every three months for the first nine months using the drug.
Women who get symptoms linked to liver damage, including nausea, vomiting, or yellowing of the skin and eyes, should contact their doctor.
Veozah must not be used with CYP1A2 inhibitors, and patients with known cirrhosis, severe renal damage or end-stage renal disease should also avoid it.
A study by the Mayo Clinic last month estimated that menopause costs US employers at least $27 billion a year through sick days and healthcare costs.
Experts said the figures demonstrate that it is in employers’ best interest to improve workplace menopause support to reduce the economic burden, such as menopause-specific sick leave and flexible working hours.
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