Chelsea Therapeutics Gets Accelerated FDA Approval For NORTHERA

(RTTNews) - Chelsea Therapeutics International, Ltd. (CHTP) said Tuesday that the U.S. Food and Drug Administration has granted accelerated approval of NORTHERATM for the treatment of symptomatic neurogenic orthostatic hypotension.

NORTHERA is the first and only therapy approved by the FDA which demonstrates symptomatic benefit in patients with neurogenic orthostatic hypotension.

NORTHERA is indicated for the treatment of orthostatic dizziness, lightheadedness, or the "feeling that you are about to black out" in adult patients with symptomatic NOH caused by primary autonomic failure, dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.

Symptomatic NOH is an autonomic nervous system disorder caused by failure to produce and or release adequate amounts of norepinephrine upon standing. Norepinephrine deficiency results in an inability for a person to maintain adequate blood pressure and blood flow to the brain when upright, frequently resulting in dizziness, lightheadedness, blurred vision, fatigue, poor concentration and fainting episodes. The disorder affects an estimated 80,000 to 150,000 individuals in the United States.

The NORTHERA approval was granted under the FDA's accelerated approval program, which allows for conditional approval of a medicine that fills a serious unmet medical need, provided additional confirmatory studies are conducted.