Drugs Xagena
The FDA ( Food and Drug Administration ) granted accelerated approval of Northera ( Droxidopa ) for the treatment of symptomatic neurogenic orthostatic hypotension ( NOH ).
Northera is the first and only therapy approved by the FDA which demonstrates symptomatic benefit in patients with NOH.
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 neurogenic orthostatic hypotension caused by primary autonomic failure ( Parkinson's disease, multiple system atrophy and pure autonomic failure ), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.
Symptomatic neurogenic orthostatic hypotension 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. These symptoms often severely limit a person's ability to perform routine daily activities that require standing or walking for both short or long periods of time. 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. The package insert indicates that effectiveness beyond 2 weeks of treatment has not yet been demonstrated, therefore the continued effectiveness of Northera in patients should be assessed periodically.
A multi-center, placebo-controlled, randomized study, which includes a 4 week randomized 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, has been preliminarily agreed to with the FDA. Based on the contemplated study design, the trial would include approximately 1,400 patients, which the FDA has agreed may be enrolled over a six year period. ( Xagena )
Source: Chelsea Therapeutics, 2014
XagenaMedicine_2014
