FDA approves drug for night sweats

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The Food and Drug Administration on Friday approved a new non-hormonal drug to treat hot flashes and night sweats that often affect people during menopause.

While not as effective as standard treatment (estrogen or estrogen plus progestin), the new prescription drug, frezolinetant, will be welcomed by those struggling with vasomotor symptoms (episodes of intense heat along with sweating and hot flashes) and not will or cannot take hormone therapy, such as breast cancer survivors. The pills will be marketed as Veozah to treat moderate to severe hot flashes, the most common symptom caused by menopause It can last several years or up to a decade or more.

“I am very excited about this FDA ruling,” said Dr. Mary Rosser, assistant professor of women’s health at Columbia University Vagelos College of Physicians and Surgeons and director of Integrated Women’s Health at Columbia. “We are talking about something that is going to be powerful.”

Rosser said the drug will be a «game changer» for women who don’t want to take hormone replacement therapy or who have been treated for hormone-sensitive cancers. That includes patients like Diane Hoard, whose hot flashes intensified soon after reaching menopause.

fezolinetan.Astellas Pharma Inc.

Hoard remembers one particularly windy and snowy winter day when the temperature hovered around 32 degrees. «I had my coat open,» he told NBC News. “I had sweat running down my forehead. I was miserable.

A prescription hormone therapy calmed the hot flashes. But a year after he started taking the drug, Hoard was diagnosed with stage 1 breast cancer and told he could no longer take hormones.

Hoard’s hot flashes came back with a vengeance, hitting her every 30 minutes, ruining her concentration and sleep.

“It’s just affecting my life tremendously,” he said.

Hoard hopes to get a prescription for the new drug.

“I’m looking to have a bit of normalcy in my life because it’s been debilitating for me,” she said.

With FDA approval, the pills could be available in pharmacies within weeks, Marci English, vice president and head of biopharmaceutical development at Astellas, the drug’s maker, said in an interview.

However, the drug is not a panacea. Hormone replacement therapy cools hot flashes in more than 90% of those who take it.

The percentages are lower with the new medication. TO phase 3 trial showed that it improved hot flashes in just under half of those who took it: 48% of women who took a higher dose and 36% of those who took a lower dose reported being much or moderately better, compared with 33% in the placebo group.

“I don’t see it as an estrogen replacement,” said Dr. Samantha Dunham, a clinical associate professor and co-director of the NYU Langone Center for Midlife Menopause and Health, who has been a consultant to the pharmaceutical company. «I see it as a non-hormonal alternative for people who can’t or don’t want to take hormone therapy.»

The drug works by targeting and blocking a receptor in the brain that regulates body temperature, according to the FDA statement.

According to Astellas, a 30-day supply is expected to cost $550.

«Unfortunately, I’m sure what’s going to be the biggest issue in my practice and everyone else’s practice is what is the price of the drug,» said Dr. Holly Thacker, director of the Cleveland Clinical Center for Women’s Specialty Health, «It’s very frustrating to have an interesting drug that works, but most patients can’t access it or can’t afford it.»

The new drug doesn’t help with other symptoms of menopause, such as thinning bones or vaginal dryness and painful sex, Dunham said.

Hot flash relief goes beyond comfort.

«The flashing light is really not good for the brain or the cardiovascular system,» Thacker said. «So, you know, you just can’t eliminate those symptoms in a lot of women.»

Clinical data showed relatively few side effects, at least in the time period covered by the trials. Some participants had abnormal values ​​on liver function tests, but those markers returned to normal after stopping the drug.


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