{"id":45555,"date":"2022-06-27T19:01:46","date_gmt":"2022-06-27T17:01:46","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/correcting-and-replacing-otsuka-pharmaceutical-and-lundbeck-announce-positive-results-showing-reduced-agitation-in-patients-with-alzheimers-dementia-treated-with-brexpiprazole\/"},"modified":"2022-06-27T19:01:46","modified_gmt":"2022-06-27T17:01:46","slug":"correcting-and-replacing-otsuka-pharmaceutical-and-lundbeck-announce-positive-results-showing-reduced-agitation-in-patients-with-alzheimers-dementia-treated-with-brexpiprazole","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/correcting-and-replacing-otsuka-pharmaceutical-and-lundbeck-announce-positive-results-showing-reduced-agitation-in-patients-with-alzheimers-dementia-treated-with-brexpiprazole\/","title":{"rendered":"CORRECTING and REPLACING Otsuka Pharmaceutical and Lundbeck Announce Positive Results Showing Reduced Agitation in Patients with Alzheimer\u2019s Dementia Treated with Brexpiprazole"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\n<i>Results from a Phase 3 clinical study for treatment of agitation in patients with Alzheimer\u2019s dementia showed that patients treated with brexpiprazole had a statistically significantly greater reduction in agitation compared to placebo<\/i>\n<\/li>\n<li>\n<i>Agitation is a very prevalent clinical manifestation in Alzheimer\u2019s dementia and one of the most complex and stressful aspects of care in patients affected by the disease. It is associated with greater caregiver burden, earlier nursing home placement, increased morbidity and mortality and a substantial economic burden.<\/i>\n<\/li>\n<li>\n<i>Currently there are no FDA approved pharmacological treatments for agitation in Alzheimer\u2019s dementia<\/i>\n<\/li>\n<\/ul>\n<p>TOKYO &amp; VALBY, Denmark&#8211;(BUSINESS WIRE)&#8211;Fifteenth paragraph of release should read: Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck. The efficacy of brexpiprazole may be mediated through a combination of antagonism at noradrenaline alpha1B\/2C receptors and serotonin 5-HT2A receptors and partial agonist activity at serotonin5-HT1A and dopamine D2 receptors.<sup>17-18<\/sup>\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20220627005184\/en\/782132\/5\/OAPI_Logo_Color_Left_1Line.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220627005184\/en\/782132\/21\/OAPI_Logo_Color_Left_1Line.jpg\"><\/a><\/p>\n<p>\nThe updated release reads:\n<\/p>\n<p class=\"bwalignc\">\n<b>OTSUKA PHARMACEUTICAL AND LUNDBECK ANNOUNCE POSITIVE RESULTS SHOWING REDUCED AGITATION IN PATIENTS WITH ALZHEIMER\u2019S DEMENTIA TREATED WITH BREXPIPRAZOLE<\/b>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\n<i>Results from a Phase 3 clinical study for treatment of agitation in patients with Alzheimer\u2019s dementia showed that patients treated with brexpiprazole had a statistically significantly greater reduction in agitation compared to placebo<\/i>\n<\/li>\n<li>\n<i>Agitation is a very prevalent clinical manifestation in Alzheimer\u2019s dementia and one of the most complex and stressful aspects of care in patients affected by the disease. It is associated with greater caregiver burden, earlier nursing home placement, increased morbidity and mortality and a substantial economic burden.<\/i>\n<\/li>\n<li>\n<i>Currently there are no FDA approved pharmacological treatments for agitation in Alzheimer\u2019s dementia<\/i>\n<\/li>\n<\/ul>\n<p>\nOtsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A\/S (Lundbeck) announce positive results of the Phase 3 clinical trial of brexpiprazole in the treatment of agitation in patients with Alzheimer&#8217;s dementia (NCT03548584). The analysis concluded that there is a statistically significant difference (p=0.0026) in the mean change from baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) total score between brexpiprazole and placebo.\n<\/p>\n<p>\nFull study results are not yet available. Further prespecified and exploratory analyses of the data set will be conducted to determine the full potential of brexpiprazole in the treatment of agitation in patients with Alzheimer&#8217;s dementia.\n<\/p>\n<p>\nBased on this outcome Otsuka and Lundbeck are planning a regulatory filing to the U. S. Food and Drug Administration (FDA) later in 2022. The Supplemental New Drug Application (sNDA) will be comprised of this study as well as two earlier trials.<sup>1<\/sup> In February 2016, the FDA granted fast track designation for brexpiprazole for treatment of agitation in patients with Alzheimer\u2019s dementia.\n<\/p>\n<p>\nOtsuka and Lundbeck are incredibly grateful to all the patients with Alzheimer\u00b4s dementia, their families and the investigators who participated in the trials and contributed greatly to this research.\n<\/p>\n<p>\nThe trial results are planned to be submitted for scientific publication at a later date.\n<\/p>\n<p>\n<b>About the Study<br \/>\n<br \/><\/b>Trial 331-14-213 (NCT03548584; Trial 213) was designed to assess the safety, tolerability and efficacy of two fixed doses of brexpiprazole (2 mg\/day and 3 mg\/day) in the treatment of patients with agitation in Alzheimer\u2019s dementia. The trial consisted of a continuous 12-week double-blind treatment period with a 30-day follow-up. The randomized trial population included 345 male and female patients, aged 55\u201390 years (inclusive), with a diagnosis of probable Alzheimer\u2019s disease, and meeting criteria of agitation as defined by the International Psychogeriatric Association (IPA). The primary outcome was the change in the CMAI total score at week 12 for all patients treated with brexpiprazole versus those treated with placebo. The key secondary outcome was the change in the Clinical Global Impression \u2013 Severity of Illness (CGI-S) score, as related to symptoms of agitation. Participating countries include Bulgaria, Hungary, Serbia, Slovakia, Spain, Ukraine, and USA. The study included both patients who were living at home and those living in institutionalized settings.\n<\/p>\n<p>\nIn the study, the improvements from baseline on the primary endpoint of CMAI for patients receiving brexpiprazole or 2 mg\/day or 3 mg\/day were statistically greater than for those receiving placebo (p=0.0026). This result was supported by a statistically superior improvement on the key secondary endpoint of CGI-S, as related to agitation (p=0.0055).\n<\/p>\n<p>\nBrexpiprazole was generally well tolerated, and no new safety signals were observed. The only treatment emergent adverse event (TEAE) with more than 5% incidence in patients treated with brexpiprazole was headache (6.6% vs. 6.9% for placebo). The following TEAEs occurred at an incidence of at least 2% in the brexpiprazole treatment group and greater than that of placebo: somnolence, nasopharyngitis, dizziness, diarrhea, urinary tract infection, and asthenia. There was one death observed in the 3 mg\/day treatment group, assessed as not related to treatment by the investigator.\n<\/p>\n<p>\n<b>About CMAI<br \/>\n<br \/><\/b>The Cohen-Mansfield Agitation Inventory (CMAI) is a caregiver rated questionnaire that measures the frequency of manifestations of 29 agitated behaviors in elderly persons, such as pacing, restlessness, yelling, and hitting.<sup>2<\/sup> It has been used extensively for assessing agitation and has been adapted and validated for different patient settings.<sup>2-5<\/sup>\n<\/p>\n<p>\n<b>About Agitation in Alzheimer\u2019s Dementia<br \/>\n<br \/><\/b>Neuropsychiatric symptoms (NPS) of Alzheimer\u2019s dementia, such as agitation are associated with poor caregiver outcomes, including reduced quality of life and poorer health.<sup>6-9<\/sup>\n<\/p>\n<p>\nAgitation is a common neuropsychiatric symptom of Alzheimer\u2019s dementia. It is reported in approximately 45% of patients with Alzheimer\u2019s dementia and has a large impact on quality of life for the patients and their loved ones.<sup>10-11<\/sup> Agitation covers a large group of behaviors occurring in patients with Alzheimer\u2019s dementia, and it is an excessive\/inappropriate manifestation of \u201cnormal\u201d human emotions and behaviors. Such behaviors include pacing, gesturing, profanity, shouting, shoving, and hitting.<sup>12<\/sup>\n<\/p>\n<p>\nSymptoms of agitation are also a consistent predictor of nursing home admission in patients with dementia.<sup>13-15<\/sup>\n<\/p>\n<p>\nAgitation in Alzheimer\u2019s dementia is thought to be associated with underlying pathophysiological circuit level dysfunctions in noradrenergic, serotonergic, and dopaminergic neurotransmission.<sup>16<\/sup>\n<\/p>\n<p>\n<b>About Brexpiprazole<br \/>\n<br \/><\/b>Brexpiprazole was approved in the U.S. on July 10, 2015, as an adjunctive therapy to antidepressants in adults with major depressive disorder and as a treatment in adults with schizophrenia. Brexpiprazole was also approved in 2017 in Health Canada and by the EMA in Europe in 2018 for the treatment of schizophrenia. In addition, brexpiprazole has been approved in several other countries across the world. Brexpiprazole is distributed and marketed under the brand name Rexulti\u00ae. In Europe, brexpiprazole is distributed and marketed under the brand name Rxulti\u00ae\n<\/p>\n<p>\nBrexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck. The efficacy of brexpiprazole may be mediated through a combination of antagonism at noradrenaline alpha1B\/2C receptors and serotonin 5-HT2A receptors and partial agonist activity at serotonin5-HT1A and dopamine D2 receptors.<sup>17-18<\/sup>\n<\/p>\n<p>\n<b>About H. Lundbeck A\/S<br \/>\n<br \/><\/b>Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best. We are committed to fighting stigma and discrimination against people living with brain diseases and advocating for broader social acceptance of people with brain health conditions. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for brain diseases for which there are few, if any therapeutic options.\n<\/p>\n<p>\nFor additional information, we encourage you to visit our corporate site <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.lundbeck.com&amp;esheet=52762654&amp;newsitemid=20220627005184&amp;lan=en-US&amp;anchor=www.lundbeck.com&amp;index=1&amp;md5=c2472bbd3817389d3d9ce007016b67b6\" rel=\"nofollow noopener\" shape=\"rect\">www.lundbeck.com<\/a> and connect with us on Instagram (h_lundbeck), Twitter at @Lundbeck and via LinkedIn.\n<\/p>\n<p>\n<b>About Otsuka<br \/>\n<br \/><\/b>Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: \u201c<!-- no quote -->Otsuka\u2013people creating new products for better health worldwide.\u201d Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.\n<\/p>\n<p>\nIn pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a \u201cbig venture\u201d company at heart, applying a youthful spirit of creativity in everything it does.\n<\/p>\n<p>\nOtsuka established a presence in the U.S. in 1973 and today its U.S. affiliates include Otsuka Pharmaceutical Development &amp; Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI). These two companies\u2019 1,700 employees in the U.S. develop and commercialize medicines in the areas of mental health, nephrology, and cardiology, using cutting-edge technology to address unmet healthcare needs.\n<\/p>\n<p>\nOPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 47,000 people worldwide and had consolidated sales of approximately USD 13.3 billion in 2020.\n<\/p>\n<p>\nAll Otsuka stories start by taking the road less traveled. Learn more about Otsuka in the U.S. at <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.otsuka-us.com&amp;esheet=52762654&amp;newsitemid=20220627005184&amp;lan=en-US&amp;anchor=www.otsuka-us.com&amp;index=2&amp;md5=ae63a1507d3eaa302bac584b81162f48\" rel=\"nofollow noopener\" shape=\"rect\">www.otsuka-us.com<\/a> and connect with us on LinkedIn and Twitter at @OtsukaUS. Otsuka Pharmaceutical Co., Ltd.\u2019s global website is accessible at <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.otsuka.co.jp%2Fen%2F&amp;esheet=52762654&amp;newsitemid=20220627005184&amp;lan=en-US&amp;anchor=www.otsuka.co.jp%2Fen%2F&amp;index=3&amp;md5=1166007b6b7c3809f75124c5f9a1e23f\" rel=\"nofollow noopener\" shape=\"rect\">www.otsuka.co.jp\/en\/<\/a>.\n<\/p>\n<p>\n<b>Citations<\/b>\n<\/p>\n<ol class=\"bwlistdecimal\">\n<li>\nGrossberg GT et al. Efficacy and Safety of Brexpiprazole for the Treatment of Agitation in Alzheimer&#8217;s Dementia: Two 12-Week, Randomized, Double-Blind, Placebo-Controlled Trials. Am J Geriatr Psychiatry. 2020;28(4):383-400\n<\/li>\n<li>\nCohen-Mansfield J. Agitated behavior in persons with dementia: the relationship between type of behavior, its frequency, and its disruptiveness. J Psychiatr Res 2008; 43: 64\u201369\n<\/li>\n<li>\nKupeli N et al. Psychometric evaluation of the Cohen-Mansfield Agitation Inventory in an acute general hospital setting. Int J Geriatr Psychiatry 2018; 33: e158\u2013e165\n<\/li>\n<li>\nde Jonghe JF, Kat MG. Factor structure and validity of the Dutch version of the Cohen-Mansfield Agitation Inventory (CMAI-D). J Am Geriatr Soc 1996; 44: 888\u2013889\n<\/li>\n<li>\nGriffiths AW et al. Validation of the Cohen-Mansfield Agitation Inventory Observational (CMAI-O) tool. Int Psychogeriatr 2020; 32: 75\u201385\n<\/li>\n<li>\nBrodaty H, Hadzi-Pavlovic D. Psychosocial effects on carers of living with persons with dementia. Aust NZ J Psychiatry 1990; 24: 351\u2013361\n<\/li>\n<li>\nKales HC et al. Assessment and management of behavioral and psychological symptoms of dementia. BMJ 2015; 350: h369\n<\/li>\n<li>\nKarttunen K et al. Neuropsychiatric symptoms and quality of life in patients with very mild and mild Alzheimer\u2019s disease. Int J Geriatr Psychiatry 2011; 26: 473\u2013482\n<\/li>\n<li>\nBrodaty H, Donkin M. Family caregivers of people with dementia. Dialogues Clin Neurosci 2009; 11: 217\u2013228\n<\/li>\n<li>\nHalpern R et al. Using electronic health records to estimate the prevalence of agitation in Alzheimer disease\/dementia. Int J Geriatr Psychiatry 2019; 34: 420\u2013431\n<\/li>\n<li>\nFillit H et al. Impact of agitation in long-term care residents with dementia in the United States. Int J Geriatr Psychiatry 2021; 36: 1959\u20131969\n<\/li>\n<li>\nCummings J et al. Agitation in cognitive disorders: International Psychogeriatric Association provisional consensus clinical and research definition.<br \/>\n<br \/>Int Psychogeriatr 2015; 27: 7\u201317\n<\/li>\n<li>\nGaugler JE et al. Predictors of nursing home admission for persons with dementia. Med Care 2009; 47: 191\u2013198\n<\/li>\n<li>\nKales HC et al. Rates of clinical depression diagnosis, functional impairment, and nursing home placement in coexisting dementia and depression. Am J Geriatr Psychiatry 2005;13:441-449\n<\/li>\n<li>\nYaffe K et al. Patient and caregiver characteristics and nursing home placement in patients with dementia. JAMA 2002;287:2090 -2097\n<\/li>\n<li>\nLiu, K. Y. et al. The neurochemistry of agitation in Alzheimer\u2019s disease: a systematic review. Ageing Research Reviews. 2018;43:99\u2013107\n<\/li>\n<li>\nMaeda K, Sugino H, Akazawa H, et al. Brexpiprazole I: <i>in vitro<\/i> and <i>in vivo<\/i> characterization of a novel serotonin\u2013dopamine activity modulator. <i>J Pharmacol Exp Ther.<\/i> 2014a;350(3):589\u2013604.\n<\/li>\n<li>\nMaeda K, Lerdrup L, Sugino H, et al. Brexpiprazole II: antipsychotic-like and procognitive effects of a novel serotonin\u2013dopamine activity modulator<i>. J Pharmacol Exp Ther<\/i>. 2014b;350(3):605\u2013614.\n<\/li>\n<\/ol>\n<p>\n\u00a0\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>MEDIA:<\/b><br \/><b>Otsuka in US<\/b><br \/>Robert Murphy<br \/>\n<br \/>Corporate Communications<br \/>\n<br \/>Otsuka America Pharmaceutical, Inc.<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#x61;&#x69;&#x6c;&#x74;&#x6f;&#x3a;&#x72;&#x6f;&#x62;&#x65;&#x72;&#x74;&#x2e;&#x6d;&#x75;&#x72;&#x70;&#x68;&#x79;&#x40;&#x6f;&#x74;&#x73;&#x75;&#x6b;&#x61;&#x2d;&#x75;&#x73;&#x2e;&#x63;&#x6f;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#114;o&#98;e&#114;t&#x2e;m&#x75;r&#x70;h&#x79;&#64;&#x6f;t&#x73;u&#x6b;a&#x2d;u&#x73;&#46;&#x63;&#111;&#x6d;<\/a><br \/>Phone: +1 609 249 7262\n<\/p>\n<p>\n<b>Otsuka in Japan<\/b><br \/>Jeffrey Gilbert (Outside the US)<br \/>\n<br \/>Leader, Pharmaceutical PR<br \/>\n<br \/>Otsuka Pharmaceutical, Co., Ltd.<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#97;i&#x6c;&#x74;&#111;:&#x67;&#x69;&#108;b&#x65;&#114;t&#x2e;&#x6a;&#101;f&#x66;&#x72;&#101;y&#x40;&#111;&#116;&#x73;&#x75;&#107;a&#x2e;&#x63;&#111;&#46;&#x6a;&#112;\" rel=\"nofollow noopener\" shape=\"rect\">&#103;i&#108;b&#101;r&#x74;&#46;&#x6a;e&#x66;f&#x72;e&#x79;&#64;&#x6f;t&#x73;u&#x6b;a&#x2e;c&#x6f;&#46;&#x6a;&#112;<\/a><br \/>Phone: +81 3 6361 7379\n<\/p>\n<p>\n<b>Lundbeck in US<\/b><br \/>Dyana Lescohier<br \/>\n<br \/>Corporate Communications<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#x61;&#x69;&#x6c;&#116;&#111;&#58;&#68;YLE&#x40;&#x6c;&#x75;&#x6e;&#x64;&#98;&#101;&#99;k&#46;c&#x6f;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#x44;&#89;&#x4c;&#x45;&#64;&#x6c;&#117;n&#x64;&#98;e&#x63;&#107;&#x2e;&#x63;o&#x6d;<\/a><br \/>Phone: +1 847 894 3586\n<\/p>\n<p>\n<b>Lundbeck in Denmark<\/b><br \/>Juliane Lenzner (Outside the US)<br \/>\n<br \/>Corporate Communications<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#x61;&#105;&#108;to&#x3a;&#x6a;&#x75;&#108;z&#64;&#x6c;&#x75;&#x6e;&#100;&#98;e&#x63;&#x6b;&#x2e;&#99;&#111;m\" rel=\"nofollow noopener\" shape=\"rect\">&#106;&#x75;l&#122;&#x40;l&#117;&#x6e;d&#x62;&#x65;&#99;&#x6b;&#46;&#99;&#x6f;m<\/a><br \/>Phone: +45 3643 4000\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Results from a Phase 3 clinical study for treatment of agitation in patients with Alzheimer\u2019s dementia showed that patients treated with brexpiprazole had a statistically significantly greater reduction in agitation compared to placebo Agitation is a very prevalent clinical manifestation in Alzheimer\u2019s dementia and one of the most complex and stressful aspects of care in &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/correcting-and-replacing-otsuka-pharmaceutical-and-lundbeck-announce-positive-results-showing-reduced-agitation-in-patients-with-alzheimers-dementia-treated-with-brexpiprazole\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-45555","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CORRECTING and REPLACING Otsuka Pharmaceutical and Lundbeck Announce Positive Results Showing Reduced Agitation in Patients with Alzheimer\u2019s Dementia Treated with Brexpiprazole - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/correcting-and-replacing-otsuka-pharmaceutical-and-lundbeck-announce-positive-results-showing-reduced-agitation-in-patients-with-alzheimers-dementia-treated-with-brexpiprazole\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CORRECTING and REPLACING Otsuka Pharmaceutical and Lundbeck Announce Positive Results Showing Reduced Agitation in Patients with Alzheimer\u2019s Dementia Treated with Brexpiprazole - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Results from a Phase 3 clinical study for treatment of agitation in patients with Alzheimer\u2019s dementia showed that patients treated with brexpiprazole had a statistically significantly greater reduction in agitation compared to placebo Agitation is a very prevalent clinical manifestation in Alzheimer\u2019s dementia and one of the most complex and stressful aspects of care in ... 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