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Thursday, July 24, 2008

Chelsea Therapeutics : MHRA Approval to Begin Phase II Trial of Droxidopa in Fibromyalgia

July 23, 2008 - Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) has received approval from the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) to begin a Phase II trial of Droxidopa, alone and in combination with carbidopa, for the treatment of Fibromyalgia.

Fibromyalgia is a chronic and debilitating condition that is characterized by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms. While the precise etiology of fibromyalgia remains unknown, current research has focused on the role of norepinephrine (NE) reuptake and availability in the central nervous system. NE, a widely used neurotransmitter in the central and peripheral nervous systems has long been linked to both chronic pain and depression. Droxidopa, a synthetic amino acid, is converted by the body into norepinephrine and as a prodrug of NE, provides replacement therapy for NE deficiency. While NE, as a catecholamine does not penetrate the blood-brain barrier, droxidopa, as a neutral amino acid, is able to do so thus providing both a peripheral and central affect on circulating NE levels... Chelsea Therapeutics' Press Release -