FDA approves new non-hormonal drug to treat hot flashes and night sweats

Posted on May 13, 2023

The Food and Drug Administration approved on Friday a new nonhormonal medication to treat the hot flashes and night sweats that often plague people during menopause.

While not quite as effective as the standard treatment — estrogen or estrogen coupled with progestin — the new prescription drug, fezolinetant, will be welcomed by those who struggle with vasomotor symptoms — episodes of intense heat along with sweating and flushing — and won't or can’t take hormonal 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 which can last for several years or as long as a decade or more.

“I’m so excited about this FDA ruling,” said Dr. Mary Rosser, an assistant professor of women’s health at the Columbia University Vagelos College of Physicians and Surgeons and director of Integrated Women’s Health at Columbia. “We’re 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 came on strong shortly after she hit menopause.

Hoard remembers a particular blustery and snowy winter day when the temperature was hovering around 32 degrees. “I had my coat wide open,” she told NBC News. “I had sweat running down my forehead. I was miserable.”

A prescription for hormone therapy quieted the hot flashes. But a year after she started taking the medication, Hoard was diagnosed with stage 1 breast cancer and told she couldn’t take hormones anymore.

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,” she said.

Hoard is looking forward to getting a prescription for the new drug.

“I’m looking to just have some normalcy back in my life because it’s been debilitating for me,” she said.

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

The medication isn’t a panacea, however. Hormone replacement therapy cools hot flashes in more than 90% of those who take it.

The percentages are smaller with the new medication. A Phase 3 trial showed that it improved hot flashes in slightly less than half of those who took it: 48% of women on a higher dose and 36% of those on a lower dose reported being much, or moderately, better, versus 33% in the placebo group.

“I don’t see it as a replacement for estrogen,” said Dr. Samantha Dunham, a clinical associate professor and co-director of the Center for Midlife Health and Menopause at NYU Langone, who has been an adviser for the drug company. “I see it as a nonhormonal alternative for people who aren’t able to or don’t want to take hormone therapy.”

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

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

“Unfortunately, the thing that’s going to be the biggest issue I’m sure in my practice and everybody else’s practice is just what the pricing of the drug is," Dr. Holly Thacker, director of the Cleveland Clinic Center for Specialized Women’s Health, said. "It’s very frustrating to have an exciting drug that works, yet most of your patients can’t get access to it or can’t afford it."

The new medication doesn't help other menopause symptoms such as thinning bones or vaginal dryness and painful sex, Dunham said.

Relief for hot flashes goes beyond comfort.

"Flashing is really not good for the brain or the cardiovascular system," said Thacker. "So, you know, you just can’t blow those symptoms off in many women.”

The clinical data showed relatively few side effects, at least in the time period covered by the trials. Some participants did have abnormal values in tests of liver function, but those markers went back to normal after the medication was discontinued.

*As of September 2024, the FDA has updated the prescribing information for Veozah (fezolinetant) to include new guidelines for liver function testing:

Before starting Veozah: Healthcare professionals should perform a baseline liver function test.
During the first three months: Patients should have their liver function tested every month.
After the first three months: Patients should have their liver function tested at months 6 and 9.
If liver function tests are elevated: Patients should stop taking Veozah immediately and contact their healthcare provider.