Chelsea Therapeutics Joins NORD in Promoting Awareness for Rare Disease Day
February 28 2014 - 7:00AM
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.
CONTACT: Media:
David Connolly
LaVoie Group
617-374-8800, Ext. 108
dconnolly@lavoiegroup.com
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