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/
Copyright Business Wire 2014