Breast-cancer survivor Rebecca Raymond was in her late 40s when she opted to have her ovaries removed, a decision that slashed her risk of a cancer recurrence but thrust her into menopause.
Rather than gradually dissipating as she aged, Ms. Raymond’s estrogen levels fell off a cliff, plunging her into a sweaty new reality. She now suffers 10 to 40 hot flashes a day. “When I say sweat, I mean it’s dripping down my face,” Ms. Raymond said. “I try not to wear makeup. There’s no point any more. And my hair – I can never style it. It just gets soaking wet.”
Ms. Raymond, a 48-year-old insurance broker, part-time roller-rink worker, and mother of two grown sons who lives in Cambridge, Ont., would love to try the most effective treatment for hot flashes: hormone replacement therapy.
But she’s been advised not to because she belongs to a category of women whose past health problems make HRT a risky prospect. Women who have had heart attacks, strokes, blood clots, liver disease and other estrogen-based cancers are in the same boat.
But now a new family of nonhormonal drugs that work directly on the body’s internal thermostat is offering hope for women in Ms. Raymond’s predicament.
Last month, the United States Food and Drug Administration approved a medication called fezolinetant for the alleviation of vasomotor symptoms, the medical term for hot flushes or flashes. The pill, sold under the brand name Veozah, is the first neurokinin-3 (NK3) receptor agonist approved by the U.S. regulator to reduce vasomotor symptoms caused by menopause.
Unlike HRT, which replaces the estrogen and progesterone women lose as their fertility wanes, NK3 receptor agonists block neural activity in an area of the brain that helps regulate body temperature. That internal control centre tends to malfunction when the brain is deprived of estrogen.
For menopausal women who can’t or won’t take HRT – many still fear the treatment because of an influential 2002 study that exaggerated the risks to women under 60 – the options for relief have been limited. The same is true for the minority of women for whom HRT doesn’t work.
Fezolinetant “could be a real game-changer,” said Wendy Wolfman, director of the menopause and premature ovarian insufficiency clinics at Mount Sinai Hospital in Toronto. She is eager to have something new to offer cancer survivors who’ve been suffering through hot flashes and night sweats for as long as a decade. “Their life is hell,” Dr. Wolfman said.
It’s not clear when fezolinetant will be available in Canada. The drug’s Japanese maker, Astellas Pharma, has applied for approval in the European Union, Switzerland, Australia, Brazil and Israel, but has yet to submit an application to Health Canada. (The company said in an e-mail that it doesn’t have any details about a Canadian application to share at this time.)
It is also not clear how the new drug stacks up against HRT when it comes to alleviating hot flashes. Fezolinetant hasn’t been tested in a head-to-head trial against hormone therapy, said Stephanie Faubion, director of the Mayo Clinic Center for Women’s Health and medical director of the North American Menopause Society.
“It appears that it’s probably not going to be as effective as hormone therapy based on the phase three trials,” Dr. Faubion said. “But it is effective.”
Possible side effects of the drug include abdominal pain, diarrhea, insomnia, back pain and hot flush, the FDA wrote in an approval notice that also advised women to be tested for liver damage before starting fezolinetant.
Until an NK3 receptor agonist is available in Canada, women in this country can turn to the North American Menopause Society’s (NAMS) new position statement on nonhormone therapy for hot flashes, released earlier this month. The expert group recommends cognitive behavioural therapy, clinical hypnosis, weight loss, and a handful of pharmaceuticals approved for other uses but which can provide moderate relief of hot flashes.
NAMS recommends against a slew of other purported treatments for hot flashes – including exercise, yoga, soy foods, cannabis, acupuncture, paced breathing and supplements and herbs – not because they don’t have any health benefits but because there is no high-quality evidence they relieve hot flashes.
“It’s not that we don’t recommend exercise,” Dr. Faubion said. “It’s just that exercise has never been shown to be effective for hot flashes. It’s good for pretty much anything else.”
Although hormones work for most women, they don’t help everyone. Trish Barbato, 58, has tried multiple forms of HRT and every nonhormone therapy possible in her eight-year fight against debilitating menopause symptoms, all to no avail.
She co-founded the non-profit Menopause Foundation of Canada to help other women, including those who, like her, need options beyond HRT. She found navigating the health system difficult, even though she works in the field as president and chief executive officer of the Arthritis Society.
“This is where I really got angry,” Ms. Barbato said. “What are women doing that are suffering needlessly and cannot get help?”