The Food and Drug Administration has approved a once-daily pill to treat uncomfortable hot flashes associated with menopause.
The new drug Veozah (fezolinetant) differs from conventional treatment by boosting the hormones estrogen and progestin to relieve menopausal symptoms such as sweating, hot flashes and chills. Developed by Astellas Pharma, Veozah blocks a chemical in the brain called neurokinin B (NKB) that regulates body temperature.
“Hot flashes associated with menopause can cause serious physical distress for women and affect their quality of life,” Janet Maynard, director of the FDA’s Office of Rare Diseases, Pediatrics, Urology and Reproductive Medicine, said in a statement. “The launch of a new molecule to treat moderate to severe hot flashes associated with menopause will provide an additional safe and effective treatment option for women.”
Hormone therapy is not useful for all patients, especially those who have been treated for breast cancer or who have had a history of stroke, blood clots, heart attacks, or other health problems.
When does menopause occur and why does it occur?
According to the National Institute on Aging, more than one million women in the United States experience menopause each year, and it is estimated that about 85% of postmenopausal women have experienced symptoms at some point in their lives. Sweats, hot flashes, and chills can last for several minutes, according to the FDA.
Menopause usually occurs between the ages of 45 and 55 as the body slowly produces less of the hormones estrogen and progesterone. The transition to menopause typically takes about seven years; Menopause is reached when there has been no menstruation for 12 consecutive months.
“Covered in Stigma”: Oprah, Drew Barrymore and Maria Shriver are open about menopause
CLIMATE NEWSSL Scientists warn that an El Niño is imminent that could burn the earth. Here’s what you should know.
This new drug addresses an “unmet need,” said Dr. Lauren Streicher, clinical professor of obstetrics and gynecology at Northwestern University and medical director of Northwestern Medicine Center for Menopause, told the New York Times. “When you think about the impact of vasomotor symptoms on work, cognitive function, sleep and quality of life, the availability of another option is exciting,” she said. “It’s something we’ve been anticipating for a long time.”
What do we know about the newly approved drug against menopause?
The FDA approved Veozah after multiple studies found it significantly reduced vasomotor symptoms (VMS), the medical term for hot flashes (also called hot flushes) and night sweats associated with menopause.
One 45 milligram pill is taken orally daily with or without food and should be taken at the same time each day. The drug carries an FDA warning of possible liver damage. According to the FDA label, women must be screened for liver damage or infection before receiving a prescription and then have blood tests every three months for nine months to watch for safety issues.
The most common side effects: abdominal pain, diarrhea, insomnia, back pain, hot flashes and increased liver enzymes.
The drug could be beneficial for people over 60, as starting hormone treatment at that age can be considered risky, Streicher, who was not involved in the study but reviewed its results, told The Times.
“The other beauty of the clinical trials is that they had a good cross-section of women — black women, Asian women, Latina women,” she said. “And it’s worked just as well for black women as it has for white women — that’s great.”
How much will the new menopause drug cost?
Tokyo, Japan-based Astellas Pharma said the drug will cost $550 for a month. This price is before insurance coverage is taken into account – and before other discounts typically negotiated by insurers and benefits managers at pharmacies.
The pills could be available in pharmacies within weeks, Marci English, vice president and head of BioPharma development at Astellas, the drug’s maker, told NBC News.
“Unfortunately, I’m sure the biggest problem in my practice and everyone else’s practice will be the pricing of the drug,” says Dr. Holly Thacker, director of the Cleveland Clinic Center for Specialized Women’s Health. told NBC News. “It’s very frustrating to have an exciting drug that works, but most of your patients don’t have access to it or can’t afford it.”
More coverage from USA TODAY
Contributors: Adrianna Rodriguez, USA Today, The Associated Press.
Follow Mike Snider on Twitter: @mikesnider.
What is everyone talking about? Sign up for our trends newsletter to get the latest news of the day