Chelsea Therapeutics has received approval from the US Food and Drug Administration (FDA) to use Northera capsules (droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension (NOH).
Northera is the first and only therapy approved by the FDA, which shows symptomatic benefit in patients with NOH, a rare, chronic and often debilitating drop in blood pressure upon standing that is related with Parkinson’s disease, multiple-system atrophy and pure autonomic failure.
Approval was granted under the FDA’s accelerated approval programme, which allows for conditional approval of a drug to treat serious unmet medical need based on clinical data showing that the drug has an effect on an intermediate clinical measure.
The FDA has agreed for a multi-centre, placebo-controlled, randomised study, which includes a four-week randomised withdrawal phase preceded by a three month open label run-in phase, designed with the goal of definitively establishing the durability of the clinical benefits of Northera.
Based on the contemplated study design, the trial would include around 1,400 patients, which the FDA has agreed may be enrolled over a six year period.
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Chelsea Therapeutics president and chief executive officer Joseph Oliveto said: "We will now turn our efforts towards delivering NORTHERA to patients with NOH in the United States, an important goal we expect to achieve in the second half of the year."
In May 2006, Dainippon Sumitomo Pharma (DSP) granted Chelsea the exclusive rights and licenses to develop and commercialise droxidopa worldwide excluding Japan, Korea, China and Taiwan.
Symptomatic NOH is an autonomic nervous system disorder caused by failure to produce and or release sufficient amounts of norepinephrine upon standing.
Symptoms of NOH are dizziness, lightheadedness, blurred vision, fatigue and fainting when a person stands.
University of South Florida Parkinson’s Disease Movement Disorders Center director Robert Hauser said: "Northera has a distinct mechanism of action affecting the root cause of NOH and represents an important new treatment choice for patients.
"It is the first and only therapy approved to address specific underlying symptoms of NOH, namely orthostatic dizziness, lightheadedness, or feeling like you might black out."
