CHARLOTTE, N.C., Feb. 28, 2014 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP), which recently received Food and Drug Administration (FDA) accelerated approval of NORTHERATM (droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension (NOH), supports raising awareness for Rare Disease Day as a member of National Organization for Rare Disorders (NORD).
"Chelsea is proud to be a member of NORD, and we applaud its leadership and advocacy on behalf of the millions of patients and their families who suffer from rare diseases and conditions," said Joseph G. Oliveto, President and Chief Executive Officer of Chelsea Therapeutics. "While we are particularly focused on supporting people with NOH, we are heartened to know there are groups like NORD that bring together advocacy efforts for thousands of rare diseases and conditions. Patients and their advocacy groups truly make a difference."
In the United States, a rare disease is defined as one that affects fewer than 200,000 persons. According to the National Institutes of Health (NIH), there are nearly 7,000 rare diseases affecting nearly 30 million Americans. In the U.S., the coalition supporting Rare Disease Day includes patient organizations, NIH and other government entities, medical researchers, hospitals and academic institutions, and pharmaceutical companies developing treatments for rare diseases. Rare Disease Day was launched in Europe in 2008 by EURORDIS, the organization representing rare disease patients in Europe. It is now observed in more than 65 nations, and is sponsored in the U.S. by NORD. For more information about Rare Disease Day activities in the U.S., go to www.rarediseaseday.us.
About Symptomatic NOH
It is estimated that 80,000 to 150,000 patients suffer from chronic symptomatic NOH in the United States. Symptomatic NOH is a chronic disorder that is caused by an underlying neurogenic disorder, such as Parkinson's disease, multiple system atrophy or pure autonomic failure. Symptoms of NOH include dizziness, lightheadedness, blurred vision, fatigue, poor concentration, and fainting episodes when a person assumes a standing position. These symptoms often severely limit a person's ability to perform routine daily activities that require standing or walking for both short and long periods of time.
NORTHERA is indicated for the treatment of orthostatic dizziness, lightheadedness, or the "feeling that you are about to black out" in adult patients with symptomatic NOH caused by primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.
The NORTHERA approval was granted under the FDA's accelerated approval program, which allows for conditional approval of a medicine that fills a serious unmet medical need, provided additional confirmatory studies are conducted. The package insert indicates that effectiveness beyond 2 weeks of treatment has not yet been demonstrated, therefore the continued effectiveness of NORTHERA in patients should be assessed periodically. A multi-center, placebo-controlled, randomized study, which includes a 4 week randomized withdrawal phase preceded by a three month open label run-in phase, designed with the goal of definitively establishing the durability of the clinical benefits of NORTHERA, has been preliminarily agreed to with the FDA.
Please see NORTHERA full Prescribing Information including Most Serious Side Effects for additional Important Safety Information at http://www.chelseatherapeutics.com.
About Chelsea Therapeutics
Chelsea Therapeutics (Nasdaq:CHTP) is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases, including central nervous system disorders. Chelsea acquired global development and commercialization rights to droxidopa (L-DOPS), or NORTHERA, from Dainippon Sumitomo Pharma Co., Ltd. in 2006, excluding Japan, Korea, China and Taiwan. For more information about the Company, visit www.chelseatherapeutics.com.
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