Lundbeck announces availability of NORTHERA™ in the U.S.
H. Lundbeck A/S (Lundbeck) announced today that NORTHERA™ (droxidopa) capsules for oral use are now available through its U.S. subsidiary Lundbeck LLC for healthcare providers to prescribe in the United States. NORTHERA™, a norepinephrine prodrug, was recently approved by the U.S. Food and Drug Administration, and is now available across the United States through a specialty pharmacy.2 NORTHERA™ is only approved for the U.S.NORTHERA™ is approved for the treatment of orthostatic dizziness, lightheadedness or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic orthostatic hypotension (NOH) caused by primary autonomic failure (Parkinson’s disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy3.
Symptomatic NOH is a rare autonomic nervous system disorder associated with failure to release adequate amounts of norepinephrine upon standing.4 NOH is caused by an underlying autonomic neurologic disorder, such as Parkinson’s disease, multiple system atrophy, or pure autonomic failure.1 Norepinephrine deficiency may result in an inability for a person to maintain adequate blood pressure and blood flow to the brain upon standing, resulting in dizziness, lightheadedness, and the “feeling that you are about to black out.”1,3,4
Contacts
Mads Kronborg, Director, Media Relations Lars Otto Andersen-Lange, Media Relations
Telephone (direct): +45 36 43 28 51 Telephone: + 45 30 83 26 57
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.
Sources
1. Freeman R. Clinical practice. Neurogenic orthostatic hypotension. N Engl J Med. 2008;358:615-624.
2. United States Food and Drug Administration. Press Release. FDA approves Northera to treat neurogenic orthostatic hypotension. February 18, 2014.
3. NORTHERA Full Prescribing Information. Deerfield, IL: Lundbeck. August 2014.
4. Freeman R, Wieling W, Axelrod FB, et al. Consensus statement on the definition of orthostatic hypotension, neurally mediated syncope and the postural tachycardia syndrome. Clin Auton Res. 2011;21:69-72.
NORTHERA is a trademark of Lundbeck NA Ltd.