FDA approves new drug for hot flashes

There were two phase 3 studies that led up to the FDA approval.

The mean age of the participants was 54. The subjects were menopausal women with one of the following situations:

The first trial included 522 women. In the second trial there were 500 participants.

The women experienced an average of seven moderate to severe vasomotor symptoms.

Participants were randomized to receive either a 45 mg dose of Veozah or a placebo. In both studies, after 12 weeks, the women receiving a placebo were re-randomized to Veozah to study the medicine’s safety further.

The researchers looked at the frequency and severity of hot flashes at weeks 4 and 12 in both studies. For the frequency of symptoms, they reportedly a clinically meaningful reduction. For severity, they noted a statistically significant decrease.

“Since Veovah is ‘the first drug of its kind’ to be FDA approved for hot flashes caused by menopause, there will be unforeseen speed bumps along the way,” said Dr, Sherry Ross, an OB/GYN and women’s health expert at Providence Saint John’s Health Center in California.

“More long-term clinical studies are needed to show Veovah’s effectiveness and common side effects experienced by people using it,” she told Medical News Today.

“The cost per month of taking Veovah is prohibitive and will single out the vast majority of people wanting to try it,” Ross added. “I would like to see the price come way down and have insurance companies cover Veovah as an alternative to hormone replacement therapy for many women in waiting.”

The most severe possible side effect is elevated hepatic transaminase (liver injury).

Before starting the medication, women are advised to have a blood test to look for liver damage. The test should be repeated every three months for the first nine months of using the medication.

Symptoms of liver damage include:

Anyone experiencing these symptoms should contact a medical professional.

People with cirrhosis or severe or end-stage renal disease are advised not take this medicine.

“My first choice would still be hormone replacement therapy if it is right for the woman,” said Dr. G. Thomas Ruiz, an OB/GYN lead at MemorialCare Orange Coast Medical Center in California. “But, I am cautiously optimistic about Veozah. We haven’t had a drug like this for hot flashes before, and it is good to have another tool to help women during menopause.”

“I would prescribe it for the right patient because the only way to find out if it works is for women to use it,” Ruiz told Medical News Today. “The study evaluated it for 52 weeks, a good time limit, and showed that it is better than a placebo and can be given safely. However, when the public uses it, which gives us much more data, we will see how it does.”

Other possible side effects include:

Abdominal pain

“For most women, menopause is a normal phase of transition of life that does not require medical intervention,” said Dr. Anita Sit, MPH, the vice chair in the Department of OB/GYN as well as the General Gynecology & Obstetrics division chief in gynecology at Santa Clara Valley Medical Center in California.

“However, some perimenopausal and postmenopausal women want to seek treatment for vasomotor symptoms, especially if their quality of life is negatively affected,” Sit told Medical News Today. “In the United States, one-half of perimenopausal women will report feeling irritated or depressed, having hot flashes and night sweats affecting the quality of life, such as insomnia and daily activities. About 50 percent of women still feel symptomatic with vasomotor symptoms five years after menopause.”

Approximately 80% of menopausal women experience hot flashes, according to Harvard Health.

“A hot flash is an abrupt and sudden feeling of electric heat in the upper chest, neck, and face, accompanied by sweating and feeling flushed,” Ross said. “They can last up to five minutes. Some women experience more than ten hot flashes a day and they can last an average of seven years.”

When these occur during sleeping hours, they are called night sweats and can disrupt sleep.

Hot flashes can also disrupt daily life. Women who get them at night might be tired during the day because of poor sleep. Women who get them during the day might find they disrupt their ability to focus on getting things done.

“Veozah is an alternative to traditional hormone replacement therapies,” Swarup said. “It’s good that women have more options. This medicine could be good for patients with contraindications to hormones. However, it has some onerous requirements for blood draws very often. I am also always concerned about the cost of new medicines and how this impacts patients.”

African American and Hispanic women have hot flashes for longer than white and Asian women, according to the National Institute of Health.

“The FDA approval of a new drug for hot flashes will be welcomed by many menopausal and perimenopausal women,” said Dr. Jennifer Wu, an ON/GYN at Lenox Hill Hospital in New York.

“The hot flashes at this time of life can be really debilitating to everyday activities and to getting a full night of sleep,” she told Medical News Today. “Traditionally hormone replacement therapy was used for hot flashes, but the risks were worrisome to patients and doctors. Veozah is not a hormone and will be a welcome addition to the treatment regimen for menopause.”

Some women prefer to try non-drug approaches first.

The National Institutes of Health recommends that women first try to discover their triggers and how much they bother you. This information can help you make better decisions about managing menopause symptoms.

“A healthy lifestyle goes a long way at any time in your life, especially during menopause,” Ross said. “Inactivity, unhealthy diet, smoking, obesity, excessive alcohol consumption, and poor sleeping habits can worsen hot flashes. Avoiding caffeine and hot and spicy foods also helps prevents mild to moderate hot flashes. Dressing in layers and carrying a portable fan are easy strategies for combating mild hot flashes.”

“Acupuncture and relaxation techniques including mindfulness, biofeedback, hypnosis, visualization, slow, deep breathing, cognitive behavior therapy, yoga, and Tai Chi may help control mild hot flashes,” Ross added. “Cognitive-behavioral therapy (CBT) and stress management techniques are also helpful for mild symptoms.”

Some people use herbs and supplements to help combat the symptoms.

“There are non-drug ways to reduce hot flashes such as dietary supplements such as black cohosh and soy (400 mg of soy extract and 50 mg isoflavone daily for six weeks),” Sit said. “However, in general, no studies substantiated the purported effects of homeopathic or other herbal remedies.”