Chelsea Therapeutics Announces FDA Advisory Committee to Review NORTHERA(TM) (droxidopa)

Chelsea Therapeutics Announces FDA Advisory Committee to Review NORTHERA(TM)

Panel Date Tentatively Set for January 14, 2014

CHARLOTTE, N.C., Oct. 9, 2013 (GLOBE NEWSWIRE) -- Chelsea Therapeutics
International, Ltd. (Nasdaq:CHTP) today announced that the U.S. Food and Drug
Administration (FDA) has notified the Company that the New Drug Application
(NDA) seeking approval to market NORTHERA™ (droxidopa), an orally active
synthetic precursor of norepinephrine, for the treatment of symptomatic
neurogenic orthostatic hypotension (NOH) will be reviewed by the
Cardiovascular and Renal Drug Advisory Committee (CRDAC). The meeting is
tentatively scheduled for January 14, 2014.

The FDA recently assigned to NORTHERA™ a Prescription Drug User Fee Act
(PDUFA) goal date of February 14, 2014.NORTHERA™ was previously granted
Orphan Drug Designation and received Fast Track designation from the FDA.
Fast Track designation is designed to facilitate the review of products that
address serious or potentially life-threatening conditions for which there is
an unmet medical need.

About Symptomatic NOH

NOH is a chronic neurogenic disorder resulting from deficient release of
norepinephrine that predominantly affects patients with primary autonomic
failure, a group of diseases which includes Parkinson's disease (PD), multiple
system atrophy (MSA) and pure autonomic failure (PAF). Symptoms of NOH
include: dizziness, lightheadedness, blurred vision, fatigue, poor
concentration, and fainting episodes when a person assumes a standing
position, often severely limiting a person's ability to perform routine daily
activities that require standing or walking for both short and long periods of

About Northera

NORTHERA™ (droxidopa), the lead investigational agent in Chelsea Therapeutics'
pipeline, is currently in Phase III development for the treatment of
symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary
autonomic failure — an indication that includes a significant number of
patients with Parkinson's disease, multiple system atrophy (MSA) and pure
autonomic failure (PAF).Droxidopa is a synthetic catecholamine that is
directly converted to norepinephrine (NE) via decarboxylation, resulting in
increased levels of NE in the nervous system, both centrally and peripherally.

Droxidopa, developed by and licensed from Dainippon Sumitomo Pharma Co., Ltd.
(DSP), initially received Japanese approval in 1989 for the treatment of
frozen gait and dizziness on standing associated with Parkinson's Disease and
for the treatment of orthostatic hypotension, syncope or dizziness on standing
associated with Shy-Drager syndrome and Familial Amyloidotic Polyneuropathy.
In 2000, Droxidopa received expanded marketing approval to include prevention
of vertigo, dizziness and weakness associated with orthostatic hypotension in
hemodialysis patients.

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 is
currently pursuing FDA approval in the U.S. for Northera™ (droxidopa), a
novel, late-stage, orally-active therapeutic agent for the treatment of
symptomatic neurogenic orthostatic hypotension in patients with primary
autonomic failure.For more information about the Company, visit

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 reliance on key
personnel and our ability to attract and/or retain key personnel; the risk
that the FDA will not agree that our clinical trial results demonstrate the
safety and effectiveness of droxidopa; the risk that the FDA will not accept
our proposal regarding any trial or other data to support a new drug
application; the risk that the FDA will not approve the resubmitted NDA; 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
any 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; risk
that we will not be able to obtain regulatory approvals of droxidopa or our
other drug candidates for additional indications; 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; and market acceptance for our products if any are
approved for marketing.

CONTACT: Investors:
         Fara Berkowitz / Susan Kim
         Argot Partners
         David Connolly
         LaVoie Group

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