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Chelsea Therapeutics Reports Significant Benefits Of Droxidopa Therapy

December 16, 2009 (FinancialWire) — Chelsea Therapeutics International, Ltd. (NASDAQ: CHTP) announced that new data from a subgroup analysis of the 44 Parkinson’s Disease patients enrolled in Study 302, a Phase III withdrawal study of Droxidopa for the treatment of symptomatic neurogenic orthostatic hypotension, demonstrated a more robust response compared to the overall study population.

Study investigators presented these data during a symposium at the XVIII WFN World Congress on Parkinson’s Disease and Related Disorders in Miami.

Study 302 evaluated the efficacy and safety of Droxidopa, a pro-drug that results in increased body stores of norepinephrine, in 101 patients with symptomatic NOH. All patients in Study 302 were evaluated for functional and symptomatic improvement through multiple endpoints including the orthostatic hypotension questionnaire . The OHQ is a global measure of disease activity consisting of a two-part questionnaire that includes the six-item orthostatic hypotension symptom assessment scale and the four-item orthostatic hypotension daily activities scale (OHDAS), along with corresponding OHSA, OHDAS and OHQ composite scores.

Results from this subgroup analysis demonstrate that PD patients, all of whom were on concomitant Levodopa/dopa-decarboxylase inhibitors, showed the strongest therapeutic response to Droxidopa. PD patients receiving Droxidopa showed improvement over placebo on 9 of the 10 individual items of the OHQ as well as all 3 composite measures.

On the four question OHDAS, the 44 PD patients on Droxidopa demonstrated a statistically significant improvement in their ability to perform activities of daily living that require standing for a short period of time (p<0.05), standing for a long time (p<0.01), and walking for a short time (p<0.05). This compares to the 101 total patients that only reported statistically significant improvements in activities that require standing for a short time (p<0.05) and standing for a long time (p<0.05).

The marked improvements observed across each of the individual OHDAS variables resulted in a highly significant benefit as measured by both the OHDAS composite (p<0.005) and the OHQ composite (p=0.005) scores for PD patients receiving Droxidopa in Study 302.

Parkinson’s disease is the second most common neurodegenerative disorder in America. As a result of decreased levels of norepinephrine associated with PD, up to an estimated 20% of these patients may experience NOH symptoms associated with the disease or as a complication of medication. NOH is a neurogenic disorder resulting from deficient release of norepinephrine, the neurotransmitter used by sympathetic autonomic nerves to send signals to the blood vessels and the heart to regulate blood pressure. This deficiency results in decreased blood pressure when a person assumes a standing position and is characterized by lightheadedness, dizziness, and syncope. Symptoms of chronic NOH can be incapacitating — not only putting patients at high risk for falls and associated injuries — but also severely affecting the quality of life of patients and their loved ones, and generating significant health care costs. The only FDA-approved treatment for orthostatic hypotension has a black box warning indicating that the drug has not been shown to be effective in alleviating the symptoms of the condition and is associated with a pronounced side-effect profile including significant supine hypertension.

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