EC grants Chelsea Therapeutics’s Droxidopa two orphan designations

These designations are based on a recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency (EMEA) and follow the previously announced orphan drug designation granted by the FDA in January 2007.

According to the EMEA, orphan medicinal products are for diagnosing, preventing or treating life-threatening or very serious conditions that are rare and affect less than five of every 10,000 persons in the EU.

“Obtaining orphan drug designations from the EMEA for both pure autonomic failure and multiple systems atrophy significantly increases the value of our Droxidopa development program,” said Simon Pedder, president and CEO of Chelsea Therapeutics. “The 10-year exclusivity afforded by these designations combined with the 10-year NCE exclusivity for the treatment of OH in Parkinson’s disease in the EU complement our existing US orphan designation and firmly establishes global exclusivity for Droxidopa.”

Symptomatic neurogenic orthostatic hypotension (NOH) is a neurogenic disorder resulting from a deficient release of norepinephrine, the neurotransmitter used by sympathetic autonomic nerves to send signals to the blood vessels and the heart. This deficiency results in decreased blood pressure when a person stands up and is characterized by lightheadedness, dizziness, blurred vision and syncope.

The company claims Droxidopa, an orally active synthetic precursor of norepinephrine, increases the supply of norepinephrine available for delivery to its receptors to improve orthostatic blood pressure and alleviate symptoms of orthostatic hypotension.