First New Treatment Option for Symptomatic
NOH in Nearly Two Decades
First and Only FDA Approved Therapy to
Demonstrate Symptomatic Benefit in Patients with NOH
Chelsea Therapeutics International, Ltd. (Nasdaq: CHTP) today
announced that the U.S. Food and Drug Administration (FDA) granted
accelerated approval of NORTHERATM (droxidopa) for the treatment of
symptomatic neurogenic orthostatic hypotension (NOH). NORTHERA is
the first and only therapy approved by the FDA which demonstrates
symptomatic benefit in patients with NOH.
NORTHERA(TM) (droxidopa) is available in
100mg, 200mg and 300mg capsules. (Photo: Business Wire)
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 approval of NORTHERA is an extraordinary achievement, one
for which I thank patients and their families, investigators and
the medical community, our partner Dainippon Sumitomo, and our
employees,” said Joseph G. Oliveto, President and Chief Executive
Officer of Chelsea Therapeutics. “We will now turn our efforts
towards delivering NORTHERA to patients with NOH in the United
States, an important goal we expect to achieve in the second half
of the year.”
Symptomatic NOH is an autonomic nervous system disorder caused
by failure to produce and or release adequate amounts of
norepinephrine upon standing. Norepinephrine deficiency results in
an inability for a person to maintain adequate blood pressure and
blood flow to the brain when upright, frequently resulting in
dizziness, lightheadedness, blurred vision, fatigue, poor
concentration and fainting episodes. These symptoms often severely
limit a person's ability to perform routine daily activities that
require standing or walking for both short or long periods of time.
1,2 The disorder affects an estimated 80,000 to 150,000 individuals
in the United States.
“Symptomatic NOH is a commonly debilitating disorder with
limited treatment options and no new therapeutic choices introduced
in nearly two decades," commented Dr. Robert A. Hauser, Professor
of Neurology, Molecular Pharmacology, and Physiology, and Director
of the Parkinson's Disease Movement Disorders Center, University of
South Florida. “NORTHERA has a distinct mechanism of action
affecting the root cause of NOH and represents an important new
treatment choice for patients. It is the first and only therapy
approved to address specific underlying symptoms of NOH, namely
orthostatic dizziness, lightheadedness, or feeling like you might
black out. I look forward to offering this new and novel treatment
approach to patients who may benefit from it.”
“This approval is a significant step forward for people with MSA
forced to cope with the debilitating effects of NOH,” said Judy
Biedenharn, Co-President of the Multiple Systems Atrophy (MSA)
Coalition. “Addressing the major symptoms of NOH can have an impact
on a person’s ability to perform even the simplest of daily
activities -- like taking a shower or standing to brush one’s teeth
-- offering an important benefit to both individuals and their
caregivers.”
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. Based on the
contemplated study design, the trial would include approximately
1,400 patients, which the FDA has agreed may be enrolled over a six
year period.
Please see NORTHERA full Prescribing Information including Most
Serious Side Effects for additional Important Safety Information at
http://www.chelseatherapeutics.com.
For product information, or to report SUSPECTED ADVERSE
REACTIONS, contact Chelsea Therapeutics, Inc. at 1-855-351-2879 or
FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
References: 1. 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. 2. Freeman R. Clinical practice.
Neurogenic orthostatic hypotension. N Engl J Med 2008;358:615-624.
3. Goldstein DS, Holmes C, Kaufmann H, Freeman R. Clinical
pharmacokinetics of the norepinephrine precursor L-threo-DOPS in
primary chronic autonomic failure. Clin Auton Res
2004;14:363-368.
About NORTHERA
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. Effectiveness beyond 2 weeks of
treatment has not been demonstrated. The continued effectiveness of
NORTHERA should be assessed periodically.
Droxidopa was initially developed by Dainippon Sumitomo Pharma
Co., Ltd. (DSP) and first commercialized in Japan in 1989.
About Chelsea Therapeutics
Chelsea Therapeutics (Nasdaq:CHTP) is a biopharmaceutical
development company that acquires, develops and commercializes
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.
This press release contains forward-looking statements regarding
future events including our intention to pursue the development of
NORTHERA . These statements are subject to risks and uncertainties
that could cause the actual events or results to differ materially.
These include the risk that we are unable to successfully
commercialize NORTHERA; the risks associated with fulfilling sales,
marketing and distribution requirements; reliance on key personnel
and our ability to attract and/or retain key personnel; the risk
that FDA will not agree that our clinical trial results demonstrate
the safety and effectiveness of droxidopa or fulfill the post
marketing requirements to achieve full approval; the risk that our
resources will not be sufficient to conduct any study of NORTHERA
that will be acceptable to the FDA; the risk that we cannot
complete Study 401 or any other additional study for NORTHERA
without the need for additional capital; the risks and costs of
drug development and that such development may take longer or be
more expensive than anticipated; our need to raise additional
operating capital in the future; our reliance on our lead drug
candidate droxidopa; the risk that we will not be able to obtain
regulatory approvals of droxidopa or our other drug candidates for
additional indications; the risk of volatility in our stock price,
related litigation, and analyst coverage of our stock; reliance on
collaborations and licenses; intellectual property risks; our
history of losses; competition; market acceptance for our products
when approved for marketing.
Photos/Multimedia Gallery Available:
http://www.businesswire.com/multimedia/home/20140218006891/en/
Media:LaVoie GroupDavid Connolly, 617-374-8800, Ext.
104dconnolly@lavoiegroup.comorInvestors:Argot PartnersSusan Kim,
212-600-1902susan@argotpartners.com
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