The US Food and Drug Administration (FDA) has scheduled a meeting of the Cardiovascular and Renal Drugs Advisory Committee on February 23, 2012 to review Chelsea Therapeutics International, Ltd's New Drug Application (NDA) for Northera (droxidopa), a orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.
The Northera NDA along with a request for Priority Review was submitted to the FDA on September 28th 2011. FDA previously granted Chelsea's request for Priority Review, and, under the Prescription Drug User Fee Act (PDUFA), FDA's goal is to review and act on the NDA by March 28, 2012. FDA grants Priority Review to drugs offering major advances in treatment, or providing a treatment where no adequate therapy exists.
The Cardiovascular and Renal Drugs Advisory Committee is an independent panel of experts that reviews and evaluates available data concerning the safety and effectiveness of products for use in the treatment of cardiovascular and renal disorders and makes appropriate recommendations to the FDA.
NOH is a chronic neurogenic disorder resulting from deficient release of norepinephrine that predominantly affects patients with primary autonomic failure, a group of diseases which includes Parkinson's disease (PD), multiple system atrophy (MSA) and pure autonomic failure (PAF). Symptoms of NOH include: dizziness, lightheadedness, blurred vision, fatigue, poor concentration, and fainting episodes when a person assumes a standing position, often severely limiting a person's ability to perform routine daily activities that require standing or walking for both short and long periods of time.
Northera (droxidopa), the lead investigational agent in Chelsea Therapeutics' pipeline, has been studied in two phase III clinical trials for the treatment of symptomatic NOH in patients with primary autonomic failure -- a group of diseases that includes Parkinson's disease, multiple system atrophy (MSA) and pure autonomic failure (PAF). Droxidopa is a synthetic catecholamine that is directly converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE in the nervous system, both centrally and peripherally. Droxidopa previously demonstrated clinical benefits in treating both intradialytic hypotension and adult attention deficit hyperactivity disorder in phase II trials and is currently being evaluated in an ongoing phase II trial for the treatment of fibromyalgia.
Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases.