Chelsea Therapeutics Initiates Phase II Study of Droxidopa in Intradialytic Hypotension

CHARLOTTE, N.C., Jan. 7, 2008 (PRIME NEWSWIRE) -- Chelsea Therapeutics
International, Ltd. (Nasdaq:CHTP) announced that last month it initiated a Phase
II trial of Droxidopa, an orally active synthetic precursor of norepinephrine,
in patients with intradialytic hypotension (IDH).

The double-blind, placebo controlled trial, being conducted at 15 sites in the
United States, is a dose response study comparing 400mg and 600mg of Droxidopa
to placebo in a total of 75 patients. Following a two-week run-in period to
establish baseline, patients in this 3-arm study will receive a single oral dose
of Droxidopa or placebo 1 hour prior to each dialysis treatment over a four-week
period (approximately 12 dialysis sessions). The study will compare the change
in mean blood pressure and symptomatic improvement during the final two weeks of
treatment to baseline established prior to drug treatment.

"Given its demonstrated success in treating the symptoms associated with
hypotension in hemodialysis patients in Japan, we are pleased to have begun our
Phase II dose response study here in the U.S.," commented Dr. Simon Pedder,
Chelsea's President and Chief Executive Officer. "There is a significant unmet
market need for a safe and effective treatment for hypotension associated with
dialysis. Based on the robust data generated to date, we believe Droxidopa will
prove to be a meaningful treatment option alleviating not only serious adverse
events and complications associated with intradialytic hypotension, but also the
disruption and repetition of dialysis sessions experienced by these patients."

Droxidopa is the Company's most advanced investigational product and is
currently in development for the treatment of neurogenic orthostatic hypotension
(NOH) as its lead indication. Chelsea plans to seek its first marketing approval
for Droxidopa in NOH following the completion of its pivotal Phase III program
in late 2008. Chelsea currently has U.S. sites open and actively screening
patients for its pivotal Phase III program.

About Droxidopa and Intradialytic Hypotension (IDH)

Intradialytic hypotension, or IDH, is the most common adverse event during
routine hemodialysis. IDH is often defined as a decrease in systolic blood
pressure by 20 mm Hg or a decrease in mean arterial pressure by 10 mm Hg. IDH
has been reported in approximately 25% of all hemodialysis patients, with
elderly patients reporting higher incidences. Many adverse hemodialysis events,
including headaches, lightheadedness, nausea, cramps, and seizures, are
associated with IDH. These complications can routinely interrupt dialysis
sessions, resulting in insufficient uremia toxin removal and necessitating
repetition of the procedure. Interruptions due to IDH increase the costs of both
the dialysis treatment sessions and the long-term care of less healthy
hemodialysis patients.

Pivotal clinical studies conducted by DSP have demonstrated the efficacy of
Droxidopa in the treatment of vertigo, dizziness and weakness associated with
hypotension in hemodialysis patients. Subsequently, in 2000, after showing
benefit in clinical trials, DSP received expanded marketing approval in Japan
for this indication.

About Chelsea Therapeutics

Chelsea Therapeutics is a biopharmaceutical development company that acquires
and develops innovative products for the treatment of a variety of human
diseases. The Company is currently developing a library of metabolically inert
antifolate compounds engineered to have potent anti-inflammatory and anti-tumor
activity to treat a range of immunological disorders. Early clinical data
suggests that Chelsea's lead antifolate compound, CH-1504, is a safe and
effective treatment alternative to methotrexate for RA and may have further
applications for psoriasis, IBD and certain cancers. Chelsea's antifolate
program is complemented by a strategic partnership with Active Biotech AB for
the joint development of a portfolio of therapeutics targeting immune-mediated
inflammatory disorders and transplantation. In addition to its autoimmune
pipeline, Chelsea is developing Droxidopa, an orally active synthetic precursor
of norepinephrine, for the treatment of neurogenic orthostatic hypotension.
Currently approved and marketed in Japan, Droxidopa has accumulated over 15
years of proven safety and efficacy, historically generating annual revenues of
approximately $50 million in Japan.

This press release contains forward-looking statements regarding future events.
These statements are just predictions and are subject to risks and uncertainties
that could cause the actual events or results to differ materially. These risks
and uncertainties include reliance on collaborations and licenses, risks and
costs of drug development, regulatory approvals, intellectual property risks,
our reliance on our lead drug candidate CH-1504, our history of losses and need
to raise more money, competition, market acceptance for our products if any are
approved for marketing, reliance on key personnel including specifically Dr.
Pedder, management of rapid growth, and the need to acquire or develop
additional products.

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CONTACT: Chelsea Therapeutics
Nick Riehle, Chief Financial Officer
704-341-1516 x101
Investor/Media Relations
Kathryn McNeil
718-788-2856