Otsuka and Lundbeck Announce Initiation of Two Phase 3 Trials of Brexpiprazole in Patients with Bipolar I Disorder
- Category: Small Molecules
- Published on Thursday, 12 October 2017 10:59
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TOKYO, Japan & DEERFIELD, IL, USA I October 11, 2017 I Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Lundbeck announce that patient enrollment has been initiated in two global Phase 3 clinical trials to evaluate brexpiprazole for the treatment of patients with manic episodes associated with bipolar I disorder.
The Phase 3 trials will evaluate the efficacy of brexpiprazole in patients with bipolar I disorder who are experiencing an acute manic episode, with or without mixed features, that requires hospitalization. The characterization of mixed features indicates that at least three symptoms of depression accompany the manic episode.
The trials are multicenter, randomized, double-blind studies of brexpiprazole versus placebo. The primary endpoint is the mean change from baseline to Day-21 endpoint in the Young-Mania Rating Scale (YMRS) total score. 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.
The key secondary endpoint is the change from baseline to Day 21 in the double-blind treatment period in Clinical Global Impression – Bipolar (CGI BP) severity-of-illness score in mania. The studies also include a number of other endpoints, including monitoring of safety and tolerability.
Brexpiprazole was approved by the U.S. Food and Drug Administration in July 2015 to treat patients with schizophrenia and as an adjunctive treatment for patients with MDD. Brexpiprazole was also approved in February 2017 by Health Canada, and in May 2017 by the Australian Department of Health, for the treatment of schizophrenia. In the three countries brexpiprazole is distributed and marketed under the brand name REXULTI®.
Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck. The mechanism of action for brexpiprazole in the adjunctive treatment of major depressive disorder or schizophrenia is unknown. However, the efficacy of brexpiprazole may be mediated through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors. Brexpiprazole exhibits high affinity (sub-nanomolar) for these receptors as well as for noradrenaline alpha1B/2C receptors.
INDICATIONS AND IMPORTANT SAFETY INFORMATION for REXULTI® (brexpiprazole)
REXULTI is indicated for:
- Use as an adjunctive therapy to antidepressants in adults with major depressive disorder
- Treatment of schizophrenia in adults
About Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.
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 45,000 people worldwide and had consolidated sales of approximately USD 11 billion in 2016.
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. Learn more about Otsuka in the U.S. at www.otsuka-us.com and connect with us on Twitter at @OtsukaUS.
H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in psychiatric and neurological disorders. For more than 70 years, we have been at the forefront of research within neuroscience. Our key areas of focus are depression, schizophrenia, Parkinson's disease and Alzheimer's disease.
An estimated 700 million people worldwide are living with psychiatric and neurological disorders 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 psychiatric and neurological disorders — we call this Progress in Mind.
Read more at www.lundbeck.com/global/about-us/progress-in-mind. Our approximately 5,000 employees in 55 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several late-stage development programmes and our products are available in more than 100 countries. We have research centres in China and Denmark and production facilities in China, Denmark, France and Italy. Lundbeck generated revenue of DKK 15.6 billion in 2016 (EUR 2.1 billion; USD 2.3 billion).
For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Twitter at @Lundbeck.
About Lundbeck in the U.S.
In the U.S., Lundbeck employs nearly 900 people focused solely on accelerating therapies for brain disorders. With a special commitment to the lives of patients, families and caregivers, Lundbeck U.S. actively engages in hundreds of initiatives each year that support our patient communities
For additional information, we encourage you to visit our corporate site www.lundbeckus.com and connect with us on Twitter at @LundbeckUS.