Menopausal symptoms

TUESDAY, Aug. 27, 2024 -- For menopausal vasomotor symptoms (VMS), elinzanetant is efficacious and well-tolerated, according to a study published online Aug. 22 in the Journal of the American Medical Association . JoAnn V. Pinkerton, M.D., from the University of Virginia Health in Charlottesville, and colleagues examined the efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist, for the treatment of moderate-to-severe menopausal VMS in two randomized, double-blind, phase 3 trials (OASIS 1 and 2), including postmenopausal participants aged 40 to 65 years. Eligible participants were randomly assigned to elinzanetant 120 mg for 26 weeks (199 and 200 in OASIS 1 and 2, respectively) or matching placebo for 12 weeks followed by elinzanetant 120 mg for 14 weeks (197 and 200 in OASIS 1 and 2, respectively). The researchers found a significant reduction in VMS frequency with elinzanetant at week 4 (−3.3 and −3.0 in OASIS 1 and 2, respectively) and week 12 (−3.2 and −3.2 in OASIS 1 and 2, respectively). In addition, the severity of VMS was improved with elinzanetant at week 4 (−0.3 and −0.2 in OASIS 1 and 2, respectively) and week 12 (−0.4 and −0.3 in OASIS 1 and 2, respectively). Improvement in sleep disturbances and menopause -related quality of life was seen with elinzanetant at week 12, and the safety profile was favorable. "Elinzanetant has the potential to provide a well-tolerated and efficacious nonhormonal treatment option to address the unmet health needs of many menopausal individuals with moderate-to-severe VMS," the authors write. Several authors disclosed ties to pharmaceutical companies, including Bayer, which manufactures elinzanetant and funded the OASIS 1 and 2 trials. Abstract/Full Text Editorial Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

THURSDAY, Aug. 22, 2024 -- A drug under development could provide a much needed option for women seeking relief from hot flashes and other menopausal symptoms, new research shows. The drug, elinzanetant, cut the frequency of hot flashes by an average of about 56% after one month of use, and by more than 65% after three months. Overall, about 62% of more than 300 postmenopausal women in two trials experienced "at least a 50% reduction in [hot flash] frequency," wrote a team led by Dr. JoAnn Pinkerton , from University of Virginia Health in Charlottesville. The drug also appeared to reduce the severity of hot flashes. The two trials were funded by elinzanetant's maker, Bayer, and published Aug. 22 in the Journal of the American Medical Association. Based in part on these results, the company announced earlier this month that it had filed a new drug application for elinzanetant with the U.S. Food and Drug Administration. According to Pinkerton's team, up to 80% of women will experience hot flashes -- medically known as menopausal vasomotor symptoms (VSM) -- during menopause , sometimes lasting for many years. Hot flashes can be debilitating and difficult to predict, and there are few therapeutic options to treat them. Decades ago, hormone replacement therapy was found to lessen hot flash severity, but further study linked it to a heightened odds for breast cancer and stroke, and many women now avoid the treatment. Certain SSRI antidepressants may help some patients. However, "many women have contraindications, have tolerability issues leading to discontinuation or prefer not to take these treatments," the study authors noted. Fezolinetant (Veozah), the first of a new class of non-hormonal drugs called neurokinin (NK)-3 receptor antagonists, gained approval from the U.S. Food and Drug Administration in 2023 for the treatment of moderate to severe hot flashes. This class of drugs targets a specific type of brain cell called KNDy neurons, known to be involved in the body's "thermoregulation." The overactivity of KNDy neurons "has been related to disruption of thermoregulation, which may trigger VMS," Pinkerton and her colleagues explained. Elinzanetant targets this mechanism to help alleviate hot flashes. The new study includes findings from two phase 3 clinical trials, each involving just over 300 postmenopausal women aged 40 to 65 (the average age was about 55). All had experienced moderate to severe hot flashes. Women were randomly given either elinzanetant (120 milligrams) or a "dummy" placebo pill to take daily for 26 weeks. The placebo effect is powerful, so women on either regimen gained some reduction in hot flash frequency and severity. However, women taking elinzanetant got significantly more relief. At the start of the trials, the average participant said she suffered through about 14 hot flashes during every 24-hour period. However, by week 4 of one of the trials, that number had fallen to less than 8 per day among women taking the placebo, and to less than 6 per day among those taking elinzanetant. By week 12, daily hot flashes had been reduced to less than 8 per day for women taking placebo and to just 4.7 per day for women on elinzanetant. The latter number represents a 65% reduction in hot flash frequency compared to the beginning of the trial. When hot flashes did occur they also tended to be less severe for those taking elinzanetant, participants reported. Women taking the drug also reported significant improvement in their sleep, the study authors said. By the end of both 26-week trials, "more than 80% of participants had achieved at least a 50% reduction" in hot flash frequency, the researchers said, suggesting that the benefits were maintained over the longer term. As to side effects, about half of participants did complain of issues such as headache or fatigue, Pinkerton's group said. "Most events were of mild intensity, and none were severe," they noted. "For women that cannot be on hormonal medication -- whether it is medically driven co-morbidities [illnesses], cardiovascular disease, hormone-responsive cancers or other reasons -- this really brings such an area of hope and positivity so that women don't have to suffer," said Dr. Stephanie McNally , director of OB/GYN services at Northwell Health's Katz Institute for Women's Health in Garden City, NY. She was not involved in the new research. Writing in a journal editorial that accompanied the study, two other experts said these drugs are already entering mainstream practice, with fezolinetant being featured in ads broadcast during this year's Super Bowl. Drs. Stephanie Faubion and Chrisandra Shufelt , of the Mayo Clinic, noted that drugs targeting the (NK)-3 receptor have already proven effective in easing insomnia. Therefore, meds like elinzanetant "may work synergistically to inhibit [hot flashes] and improve sleep," they theorized. There's even a hint from early research that (NK)-3 receptor inhibition could prevent the excess fat deposits around a woman's middle that can come with menopause . So, drugs like fezolinetant and elinzanetant "could also potentially inhibit the known increase in visceral fat associated with the menopause transition," Faubion and Shufelt reasoned. The bottom line: "With the discovery of non-hormonal treatment options targeting the neurons responsible for VMS, menopause care should advance on this solid scientific footing to benefit affected individuals," the two experts wrote. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Astellas is returning to the Super Bowl to help educate game viewers about VEOZAH and vasomotor symptoms (VMS), the most commonly reported menopause symptoms1 The "Fewer Hot Flashes, More Not Flashes" ad features women experiencing common moderate to severe hot flash and night sweat moments that impact their daily lives NORTHBROOK, Ill., Feb. 1, 2024 /PRNewswire/ -- Astellas Pharma US, Inc. (President: Mark Reisenauer, "Astellas") today announced that it will air a new version of its commercial for VEOZAH® (fezolinetant) just before Super Bowl kickoff on Sunday, February 11, 2024. VEOZAH is a nonhormonal treatment option approved by the U.S. Food and Drug Administration (FDA) to reduce the frequency and severity of moderate to severe vasomotor symptoms (VMS), also known as hot flashes and night sweats, due to menopause.1,2 The "Fewer Hot Flashes, More Not Flashes" TV spot is expected to reach millions of women in the U.S. tuning in who may be experiencing VMS due to menopause, as well as their partners, friends, and family.3,4 Jill Jaroch, Senior Director, Women's Health, Astellas "Approximately half of the audience are women, making the Super Bowl an incredible platform to showcase the different types of hot flash moments women in midlife may experience.4 At Astellas, we want all women to feel heard and their unique needs to be validated, which is why we are continuing to elevate this conversation. After all, nearly half of women in the U.S. going through menopause may experience moderate to severe VMS.3 We want to empower them to talk openly about their experiences and to have more informed discussions with their healthcare providers about VEOZAH." The TV spot showcases relatable hot flash moments, emphasizing that fewer interruptions from moderate to severe VMS due to menopause can be possible.2 When women with VMS are not having a hot flash, that's a not flash. The ad, as part of a larger consumer campaign, aims to encourage women to speak up and seek appropriate treatment options with their healthcare providers. To find more information about moderate to severe VMS due to menopause and this nonhormonal treatment option, visit VEOZAH.com. About VEOZAH® (fezolinetant) VEOZAH ® (fezolinetant) is a neurokinin 3 (NK3) receptor antagonist approved in the U.S. for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause.2 VEOZAH is not a hormone.2 VMS are the feelings of warmth in the face, neck, and chest, or sudden intense feelings of heat and sweating ("hot flashes" or "hot flushes").1 VEOZAH works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin B/dynorphin (KNDy) neuron to modulate neuronal activity in the thermoregulatory center of the brain (the hypothalamus) to reduce the frequency and severity of moderate to severe VMS due to menopause.1,2 About VMS due to Menopause VMS, characterized by hot flashes (also called hot flushes) and/or night sweats, are common symptoms of menopause.1 In the U.S., nearly half of women going through menopause may experience moderate to severe VMS.3 VMS can have a disruptive impact on women's daily activities and overall quality of life.5 U.S. Important Safety Information Do not use VEOZAH if you: have cirrhosis. have severe kidney problems or kidney failure. are taking certain medicines called CYP1A2 inhibitors. Ask your healthcare provider if you are not sure. Before you use VEOZAH, tell your healthcare provider about all of your medical conditions, including if you: have liver disease or problems. have kidney problems. have any medical conditions that may become worse while you are using VEOZAH. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VEOZAH may affect the way other medicines work, and other medicines may affect how VEOZAH works. What are the possible side effects of VEOZAH? VEOZAH can cause serious side effects, including: increased liver blood test values. Your healthcare provider will do a blood test to check your liver before you start taking VEOZAH. Your healthcare provider will also do this blood test at month 3, month 6, and month 9 after you start taking VEOZAH. Call your healthcare provider right away if you have the following signs and symptoms of liver problems: nausea vomiting yellowing of the eyes or skin (jaundice) pain in the right upper stomach (abdomen) The most common side effects of VEOZAH include: stomach (abdominal) pain diarrhea difficulty sleeping (insomnia) back pain hot flashes or hot flushes These are not all the possible side effects of VEOZAH. Tell your healthcare provider if you have any side effect that bothers you or does not go away. Call your healthcare provider for medical advice about side effects. You may report side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. For more information, please see the full Prescribing Information and Patient Product Information for VEOZAH (fezolinetant). About Astellas Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at . Cautionary Notes In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. References 1 Thurston RC. Vasomotor symptoms. In: Crandall CJ, Bachman GA, Faubion SS, et al., eds. Menopause Practice: A Clinician's Guide. 6th ed. Pepper Pike, OH: The North American Menopause Society, 2019:43-55. 2 Veozah [package insert]. Northbrook, IL: Astellas Pharma US, Inc. 3 Freeman EW, Sammel MD, Sanders RJ. Risk of long-term hot flashes after natural menopause: evidence from the Penn Ovarian Aging Study cohort. Menopause 2014;21(9):924-32. 4 Men, Women and the Super Bowl: The Science Marketers Should Note, Martec Group. 5 English M, Stoykova B, Slota C, et al. Qualitative study: burden of menopause-associated vasomotor symptoms (VMS) and validation of PROMIS sleep disturbance and sleep-related impairment measures for assessment of VMS impact on sleep. J Patient Rep Outcomes 2021;5(37):1-13. SOURCE ASTELLAS PHARMA INC.