FDA Approves Chelsea Therapeutic's Northera For Neurogenic Orthostatic Hypotension

The Food and Drug Administration (FDA) announced in a press release that it approved Northera capsules for neurogenic orthostatic hypotension (NOH). The approval under the FDA’s accelerated approval program is the first therapy granted for symptomatic relief in patients with NOH. Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research said, “People with neurogenic orthostatic hypotension are often severely limited in their ability to perform routine daily activities that require walking or standing. There are limited treatment options for people with NOH and we are committed to helping make safe and effective treatments available.”

NOH

Neurogenic Orthostatic Hypotension (NOH) is associated with several conditions including pure autonomic failure, Parkinson’s disease, and multiple-system atrophy. NOH is caused by a drop in blood pressure. Patients feel dizzy, fatigued, lightheaded, and may faint upon standing. Autonomic nervous system (ANS) deficits cause NOH. Those with existing neurological diseases experience NOH, but heart problems, dehydration, and some medications can cause hypotension. 

Northera

Northera (droxidopa) is an oral preparation of a norepinephrine precursor. The synthetic amino acid analog metabolizes into the vasopressor, norepinephrine. With more norepinephrine, the blood vessels constrict or tighten, increasing blood pressure and decreasing symptoms of NOH. The drug may increase blood pressure when lying down (supine hypertension) and may lead to stroke. Patients must sleep with the upper body and head elevated. Blood pressure should be monitored while on treatment. Side effects include fatigue, nausea, and dizziness.

Northera’s effectiveness was shown in two clinical trials. Participants reported decreases in NOH symptoms. The drug was approved under the FDA’s accelerated approval program, which reviews drugs for serious diseases. Patients can access the drugs while the sponsor conducts clinical trials to verify the treatment’s benefits. The FDA has classified Northera as an orphan drug. Orphan drug sponsors may qualify for incentives, including tax credits for clinical trials. 

About Chelsea Therapeutics  

Chelsea Therapeutics develops products for central nervous system disorders. The company acquired the rights to Northera from Dainippon Sumitomo Pharma Co., Ltd. in 2006. Chelsea has a portfolio of agents, metabolically inert antifolates, indicated for the treatment of rheumatoid arthritis and other autoimmune disorders.

Source:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm386311.htm