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Lundbeck and Otsuka report phase III data evaluating brexpiprazole for the treatment of manic episodes associated with bipolar I disorder | ||
By: Nasdaq / GlobeNewswire - 14 Feb 2019 | Back to overview list |
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Valby, Denmark and Tokyo, Japan, 14 February 2019 H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announce today that data from two global Phase III clinical trials evaluating the safety and efficacy of brexpiprazole for the treatment of patients with manic episodes associated with bipolar I disorder did not meet the primary endpoint. The duration of the randomized phase of each trial was 3 weeks. The two multicenter, randomized, double-blind studies of brexpiprazole versus placebo comprised a total of approximately 650 bipolar I patients who experienced an acute manic episode, with or without mixed features, that required hospitalization. The primary efficacy measure to assess the psychiatric signs and symptoms was determined using the Young Mania Rating Scale (YMRS). The YMRS score is a widely-used clinician rating scale to assess mania symptoms based on a patient’s subjective reports of their condition and clinical observations made during interviews.i The studies did not meet the primary endpoint of statistical separation from placebo as measured by the Young Mania Rating Scale (YMRS) at week 3. In both studies, the placebo effect on the rating scales was substantially higher than anticipated. Brexpiprazole was generally well tolerated in the trials. The most common adverse reactions observed during the trials were akathisia (6.5%) and headache (5%) and no other adverse events was greater than 3% for patients receiving brexpiprazole across the 2 studies The companies will conduct a thorough analysis of the study results to determine what the next steps will be. The results from the bipolar 1 disorder mania studies do not have any bearing on the approved indications of brexpiprazole as treatment for people living with major depressive disorder (MDD) and schizophrenia. About the Studies About Bipolar I Disorder About Brexpiprazole Lundbeck contacts Otsuka contacts
About H. Lundbeck A/S An estimated 700 million people worldwide are living with brain diseases and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind. Read more at www.lundbeck.com/global/about-us/progress-in-mind. Our approximately 5,000 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several late-stage development programs and our products are available in more than 100 countries. Our research center is based in Denmark and our production facilities are located in Denmark, France and Italy. Lundbeck generated revenue of DKK 18,1 billion in 2018 (EUR 2,4 billion; USD 2,8 billion). For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Twitter at @Lundbeck and via LinkedIn. About Otsuka Pharmaceutical Co., Ltd. In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a "big venture" company at heart, applying a youthful spirit of creativity in everything it does. Otsuka Pharmaceutical is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 46,000 people worldwide and had consolidated sales of approximately € 9.8 billion (USD 11.1 billion) in 2017. All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at https://www.otsuka.co.jp/en. References i PsychTools. http://www.psychtools.info/ymrs/. Accessed February 11, 2019 ii Epidemiology of DSM-5 bipolar I disorder: Results from the national epidemiologic survey on alcohol and related conditions - III. Blanco C, Compton WM, Saha TD et al. J Psychiatr Res 84 (2017) 310-317.
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