Menopausal syndrome

On October 9, Bayer officially announced that its New Drug Marketing Application (NDA) has been accepted by the US Food and Drug Administration (FDA). The application is for Elinzanetant (Elinetant), a dual NK-1/NK-3 receptor antagonist, indicated for moderate to severe vasomotor symptoms (VMS) associated with menopause, commonly known as menopausal hot flashes. The application is based on the positive results of three Phase III clinical studies, OASIS 1, OASIS 2, and OASIS 3. These studies were designed to comprehensively evaluate the efficacy and safety of Elinzanetant in the treatment of menopausal associated VMS. The results of the study showed that Elinzanetant (120mg orally once daily) was excellent in reducing the frequency and severity of moderate-to severe VMS and demonstrated a good safety profile. In the Elinzanetant treatment group, headache and fatigue were the most common adverse events. In addition, the OASIS 1 and OASIS 2 studies observed sustained improvements across three key secondary endpoints, including a significant reduction in VMS frequency at week 1, improvements in sleep disturbances, and improvements in menopause-related quality of life. Elinzanetant is an innovative dual NK-1 and NK-3 receptor antagonist whose unique mechanism of action lies in the regulation of a group of estrogen-sensitive neurons within the hypothalamus in the brain (KNDy neurons). During menopause, KNDy neurons become hypertrophic due to decreased estrogen levels and lead to overactivation of the thermoregulatory pathway, which in turn disrupts the body temperature control mechanism and triggers VMS. Hot flashes, one of the most common symptoms of menopause, have a significant negative impact on women's quality of life. It is predicted that by 2030, 1.2 billion women worldwide will be affected by menopausal hot flashes. In addition to the OASIS project, Bayer is actively advancing the NIRVANA (NCT06112756) study, which aims to further evaluate Elinzanetant in the treatment of menopausal related sleep disorders.

BERLIN, Germany I October 09, 2024 I Bayer today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for the investigational compound elinzanetant seeking approval for the treatment of moderate-to-severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause. “The NDA acceptance of elinzanetant by the FDA marks a significant milestone in our efforts to advance menopause care for women in the U.S.,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization, Member of the Pharmaceutical Leadership Team at Bayer.“If approved, elinzanetant will offer a new non-hormonal option to women seeking treatment for moderate to severe vasomotor symptoms and we look forward to the review by the agency.” The NDA application is based on the positive results from the OASIS 1, 2 and 3 Phase III studies evaluating the efficacy and safety of the investigational compound elinzanetant versus placebo. Findings from OASIS 1 and 2 were published in August 2024 in JAMA . 1 Detailed results of the Phase III study OASIS 3 providing supporting efficacy and additional long-term safety data were presented at The Menopause Society (TMS) annual meeting in September 2024. Bayer is continuing to submit applications for marketing authorizations of elinzanetant to further health authorities as well. About the Elinzanetant clinical development program The Phase III clinical development program of elinzanetant, OASIS, currently comprises four Phase III studies: OASIS 1, 2, 3 and 4. OASIS 1 and 2 investigated the efficacy and safety of elinzanetant administered orally once daily in women with moderate to severe VMS associated with menopause over 26 weeks and randomized 396 and 400 postmenopausal women between 40 and 65 years across 184 sites in 15 countries. Patients in the elinzanetant arm received a 120 mg dose of elinzanetant once daily for 26 weeks and patients in the control arm received a matching placebo once daily for 12 weeks, followed by elinzanetant 120 mg dose for 14 weeks. OASIS 3 investigated the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms over 52 weeks in postmenopausal women and randomized 628 postmenopausal women between 40 and 65 years across 83 sites in 9 countries. The OASIS 4 study is an expansion of the clinical Phase III program and investigates the efficacy and safety of elinzanetant in women with moderate to severe VMS caused by endocrine therapy for treatment or prevention of breast cancer. In addition to the OASIS program, Bayer is conducting NIRVANA (NCT06112756), an exploratory Phase II randomized, parallel-group treatment, double-blind study. The primary objective is to explore the efficacy of elinzanetant on sleep disturbances associated with menopause (SDM) as determined by polysomnography (PSG). PSG is a validated method to study sleep and underlying causes of sleep disturbances. Additional objectives include exploring the efficacy of elinzanetant on SDM as determined by patient-reported outcomes and further evaluating the safety of elinzanetant. About Elinzanetant Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist, in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause, administered orally once daily. Elinzanetant may address moderate to severe VMS by modulating a group of estrogen sensitive neurons in the hypothalamus region of the brain (the KNDy neurons) which, with the decrease of estrogen, become hypertrophic and lead to a hyperactivation of the thermoregulatory pathway, consequently disrupting body heat control mechanisms resulting in VMS. Based on key secondary endpoints of OASIS 1 and 2, Elinzanetant may also decrease sleep disturbances associated with menopause. About Vasomotor Symptoms Vasomotor symptoms (VMS; also referred to as hot flashes) result from hyperactivation of the thermoregulatory pathway mediated by hypertrophy of the KNDy neurons. This is due to a decrease of estrogen, which can result from the progressive reduction of ovarian function due to natural menopause or medical intervention by bilateral oophorectomy or endocrine therapy. VMS are reported by up to 80% of women at some point during the menopausal transition and are one of the leading causes for seeking medical attention during this phase of a woman’s life. Over one-third of menopausal women report severe symptoms, which can last 10 years or more after the last menstrual period, with relevant impact on quality of life. VMS may also be caused by endocrine therapy, for the treatment or prevention of breast cancer, impacting quality of life and treatment adherence. For these women, there are currently no approved treatment options. About Menopause By 2030, the global population of women experiencing menopause is projected to increase to 1.2 billion, with 47 million women entering this phase each year. Menopause is a transitional phase in women’s lives, related to the progressive decline of ovarian function. It usually occurs in women during their 40s or early 50s. It can also be the result of surgical or medical treatment such as breast cancer treatment. The hormonal decline can lead to various symptoms which can substantially affect a woman’s health, quality of life, healthcare utilization and work productivity. The most frequently reported and disruptive symptoms during the menopausal transition are VMS, sleep disturbances and mood changes. Addressing these symptoms is key to maintaining functional ability and quality of life in menopause which is highly relevant from both a healthcare and socio-economic perspective. About Women’s Healthcare at Bayer Women’s Health is in Bayer’s DNA. As a global leader in women’s healthcare Bayer has a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low-and-middle income countries by 2030 with access to family planning by funding multi-stakeholder aid programs for capacity building and by ensuring the supply of affordable modern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com . Find more information at https://pharma.bayer.com/ Follow us on Facebook: http://www.facebook.com/bayer Follow us on LinkedIn: Bayer | Pharmaceuticals 1 https://jamanetwork-com.libproxy1.nus.edu.sg/journals/jama/fullarticle/2822766 SOURCE: Bayer

HENDERSON, Nev., April 15, 2024 (GLOBE NEWSWIRE) -- Nika Pharmaceuticals, Inc. (OTCMKTS: NKPH) announces the purchase of four technologies for production of three generic drugs in tablet form and one dietary supplement. The acquisition includes full dossiers for each product, which will allow NKPH to quickly register them for sale once the company has finalized the branding of each. The technologies, which were purchased through NKPH’s subsidiary, Nika Europe Ltd., have a proven market track record, as each of them satisfy an important health need of the population. The positive effect of each may be summarized as follows: VINPOCETINE 10mg is clinically tested and has been used for over thirty years for the treatment of stroke, dementia, and other brain disorders due to its neuroprotective abilities. Vinpocetine enhances memory and brain metabolism whilst increasing oxygen transportation to the tissues and blood circulation in the brain; it reduces peripheral vascular resistance and unhealthy blood viscosity. Vinpocetine significantly increases the resiliency of brain cells to lack of oxygen. MENTHYL VALERATE 60mg is an over-the-counter drug with a positive effect on the central nervous and cardiovascular systems. Due to its soothing properties, it is generally used in people who are subject to daily stress, suffering from insomnia, or with anxiety disorders. Menthyl Valerate is also used as symptomatic treatment of kinetoses and neurovegetative dystonias. METAMIZOLE SODIUM 500mg is an antipyretic and analgesic drug most commonly used to relieve pain resulting from headaches, surgery, toothache, muscle aches, menstrual pain, etc. Metamizole Sodium is also used against fever on its own or as part of complex therapy of acute inflammatory diseases of the upper respiratory tract, tracheitis and tracheobronchitis, infectious diseases. TRIBULUS TERRESTRIS HERBA EXTRACTUM SICCUM 250mg is a dietary supplement that is used in complex therapies for men suffering from reduced libido, impotence, male infertility, lipid metabolism disorder or in women with climacteric and postcastration syndrome or endocrine sterility. Studies show increased sexual function from men suffering from erectile dysfunction, as well as increase in testosterone levels. Tribulus Terrestris is also used by bodybuilders and men with active lifestyles. “The purchase of these technologies for production further extends our portfolio of products and will allow us to satisfy demand for such widely used drugs in fringe markets in certain parts of Asia and Africa where supply is severely lacking,” stated Dimitar Savov, CEO of Nika Pharmaceuticals, Inc. “Now that the first batches of our dietary supplements Physiolong, Carotilen, Hypocholestin, Biodetoxin, Silymaron, and Anthocylen C have been produced and entered the Bulgarian market, we are working tirelessly toward establishing strong partnerships for the distribution of our current and newly acquired products,” continued Savov. Additional information can be found via NKPH’s published disclosures on . About Nika Pharmaceuticals, Inc. Nika Pharmaceuticals, Inc. (NKPH) is a pharmaceutical company, which specializes in the treatment of HIV/AIDS, Hepatitis B and C, Rheumatoid Arthritis, Cancer, Diabetes, and all diseases, for which strengthened cell immunity is of vital importance. NKPH's intellectual property includes six drugs in injection form – two of which have successfully undergone clinical trials with good treatment results – three drugs in tablet form, and nine dietary supplements. NKPH’s goal is to not only achieve corporate profits, but to provide better and easier access to life-saving medicinal drugs and useful dietary supplements. Find more on . Forward-looking Statement: This press release contains forward-looking statements. Certain statements, other than purely historical information, including estimates, projections, statements relating to our business plans, objectives, and expected operating results, and the assumptions upon which those statements are based, are “forward- looking statements.” These forward-looking statements generally are identified by the words “believes,” “expects,” “anticipates,” “intends,” “strategy,” “plan,” “may,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Forward-looking statements are based on current expectations and assumptions that are subject to risks and uncertainties which may cause actual results to differ materially from the forward-looking statements. Our ability to predict results or the actual effect of future plans or strategies is inherently uncertain. CONTACT Clifford Redekop, Corporate Secretary COMPANY Nika Pharmaceuticals, Inc. PHONE (702)-326-3615 EMAIL info@nikapharmaceuticals.com WEB