Lundbeck Canada Inc. Announces Health Canada Approval of Trintellix™ (vortioxetine hydrobromide) for Treatment of Adults with Major Depressive Disorder

MONTREAL, Oct. 28, 2014 /CNW/ - Lundbeck Canada Inc. announced today that Health Canada has approved Trintellix^TM (vortioxetine hydrobromide) for the treatment of major depressive disorder (MDD), a debilitating mental health illness which affects more than 1 in 10 Canadians over the age of 18¹ and occurs about twice as often in women than in men^1,2,3.

"MDD manifests itself through a wide array of emotional, physical and cognitive symptoms. Beyond the mood component, changes in appetite and psychomotor activity, difficulty concentrating and making decisions, or even suicidal behaviour, are common. These symptoms can be felt by sufferers on a daily basis, often throughout the day, and seriously impede their ability to function" says Dr. Roger McIntyre, Full Professor of Psychiatry and Pharmacology at the University of Toronto and Head of the Mood Disorders Psychopharmacology Unit at the University Health Network. "With such a diverse group of symptoms, it is important to find diversity in treatment to improve patient outcomes."

About Trintellix^TM

Trintellix is a novel agent indicated for the treatment of major depressive disorder (MDD) in adults. Trintellix is an inhibitor of serotonin (5-HT) reuptake and also an agonist at 5-HT1A receptors, a partial agonist at 5-HT1B receptors and an antagonist at 5-HT3, 5-HT1D and 5-HT7 receptors. The efficacy of Trintellix in providing symptomatic relief of MDD was demonstrated in controlled clinical trials. The efficacy of Trintellix in maintaining an antidepressant response for up to 24 weeks was demonstrated in a controlled trial in patients with MDD who initially responded to an acute, open label treatment with Trintellix.⁴

"One can hope for better management of MDD symptoms, or one can act," says Patrick Cashman, President and General Manager of Lundbeck Canada Inc. "With the approval of Trintellix by Health Canada, we strive to offer new alternatives to Canadian patients living with MDD who deserve better treatment. This is why we keep pushing boundaries, trying to improve the daily lives of people who live with mental illness."

Trintellix will be made available in Canada by December 2014.

Burden of Depression

According to The World Health Organization, fewer than half of people with depression worldwide are receiving treatment⁵, and the burden of depression is expected to continue to rise globally⁶. For those who do seek treatment, discontinuation is not uncommon^7,8. MDD is a heterogeneous disorder that does not consistently respond to therapy, thus it's important for patients to work with a healthcare provider to help find a treatment plan that works for them⁹.

About Lundbeck

H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in brain diseases. For more than 50 years, we have been at the forefront of research within neuroscience. Our key areas of focus are alcohol dependence, Alzheimer's disease, bipolar disorder, depression/anxiety, epilepsy, Huntington's disease, Parkinson's disease, schizophrenia, stroke and symptomatic neurogenic orthostatic hypotension (NOH).

An estimated 700 million people worldwide are living with brain disease 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 disease – we call this Progress in Mind.

Read more at www.lundbeck.com/global/about-us/progress-in-mind. 

Our approximately 6,000 employees in 57 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 100 countries. We have research centres in China, Denmark and the United States and production facilities in China, Denmark, France and Italy. Lundbeck generated revenue of approximately DKK15.3 billion in 2013 (EUR2.1 billion; USD2.7 billion).

For additional information, we encourage you to visit our corporate site www.lundbeck.com.

About Lundbeck Canada Inc.

Established in Montreal since 1995, Lundbeck Canada Inc. is a subsidiary of H. Lundbeck A/S, an international pharmaceutical company dedicated to research. With a primary focus on mental health disorders and a recent entry into the field of oncology, Lundbeck places the needs of those who live with these illnesses at the heart of its priorities. Whether it is conducting fundamental research, developing innovative medications or forging partnerships, Lundbeck constantly challenges the status quo because Canadians with mental illness or cancer deserve better. www.lundbeck.com/ca/en

References

¹ Government of Canada. The Human Face of Mental Health and Mental Illness in Canada, 2006. Minister of Public Works and Government Services Canada. Catalogue no.: HP5-19/2006E.
² Weissman MM, Bland RC, Canino GJ, Faravelli C, Greenwald S, Hwu H-G, Joyce PR, Karam EG, Lee C-K, Lellouch J, Lepine J-P, Newman SC, Rubio-Stipe M, Wells E, Wickramaratne PJ, Wittchen H-U, Yeh E-K. Cross-National epidemiology of major depression and bipolar disorder. JAMA 1996; 276(4):293-299.
³ Beaudet MP. Psychological health – depression. Health Reports 1999; 11(3):63-75.
⁴Trintellix^TM Product Monograph, Lundbeck Canada Inc., October 22, 2014.
⁵Depression. Retrieved August 2 from: http://www.who.int/mediacentre/factsheets/fs369/en/index.html.
⁶ The World Health Organization (2008). The Global Burden of Disease: 2004 Update.
⁷ Hunot, V., Horne, R., Leese, M., Churchill, R. (2007). A Cohort Study of Adherence to Antidepressants in Primary Care: The Influence of Antidepressant Concerns and Treatment Preferences. Primary Care Companion, Journal of Clinical Psychiatry; 9(2):91-99.
⁸Bull, S., et al (2002). Discontinuing or Switching Selective Serotonin-Reuptake lnhibitors. The Annals of Pharmacotherapy; 36: 578-584.
⁹ Gotto, J., Rapaport, M. (2005). Treatment Options in Treatment-Resistant Depression. Primary Psychiatry; 12(2):42-50.

SOURCE: Lundbeck Canada Inc.

Contacts: Stephanie Convery, Weber Shandwick, [phone], [email protected]; Daniel McCarthy, Lundbeck Canada Inc., 514.940.7711, [email protected]