Chelsea Therapeutics : New Patent for Use of Droxidopa in Fibromyalgia

Sept. 6, 2011 -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that the United States Patent and Trademark Office has issued U.S. Patent No. 8,008,285 entitled "Droxidopa and pharmaceutical composition thereof for the treatment of fibromyalgia." The claims of the patent are related to methods of reducing pain associated with fibromyalgia by administering droxidopa alone, or in combination with other specified medications, to patients diagnosed with fibromyalgia. Chelsea recently completed enrollment of 120 patients in its Phase II trial of droxidopa for the treatment of fibromyalgia. Top-line results of the trial are expected by the end of the year.

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 -

Chelsea Therapeutics : Positive Interim Analysis of Phase II Trial of Droxidopa in Fibromyalgia

July 1, 2010 - Independent Data Monitoring Committee Sees Meaningful Efficacy in Multiple Treatment Arms Trial Focusing on Novel Droxidopa/Carbidopa Combination Therapy No Significant Adverse Events or Safety Concerns Observed in Any Treatment Arm - Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced the completion and favorable outcome of an independent Data Monitoring Committee (DMC) review of the safety and efficacy data from approximately half the target enrollment in Chelsea's Phase II trial of droxidopa in fibromyalgia.

The purpose of this scheduled DMC meeting was to review the efficacy of each dose group and determine if the efficacy data supported dropping underperforming arms in order to increase the power in those arms most likely to demonstrate a clinically relevant therapeutic benefit. Following their assessment of each of the 12 arms using the study's primary endpoint, a reduction in pain as measured by the Short Form McGill Pain Questionnaire, the DMC recommended that 7 of the 12 arms of the trial be continued to completion. This recommendation was based solely on their efficacy analysis, as there were no observed safety concerns associated with any arm of the study. As a result of this recommendation, the study will now focus primarily on multiple doses of droxidopa in combination with 50mg carbidopa.

"The DMC's recommendation aligns with our assumption going into the trial that by pairing droxidopa with carbidopa to limit peripheral metabolism of droxidopa, we should be able to drive efficacy of droxidopa in the treatment of fibromyalgia... Chelsea Therapeutics' Press Release -

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 -