Droxidopa Approved for Parkinson’s-Related Hypotension


Droxidopa-Approved-for-Parkinsons-Related-HypotensionThe FDA recently approved Droxidopa, known as the brand name Northera, to treat neurogenic orthostatic hypotension, which is a common complication of Parkinson’s disease. Neurogenic orthostatic hypotension or NOH is an uncommon but dangerous drop in blood pressure that presents upon standing. Patients with NOH exhibit symptoms like severe dizziness, a faint feeling, weakness, fatigue and blurry vision. This debilitating condition leads to difficulties for patients with Parkinson’s to complete normal day to day tasks, such as walking, standing up from a sitting or lying down position and any type of exercise.  The approval of Droxidopa is a relief for this patient population, as it helps to return a semblance of normalcy to the lives of these patients. Approved under an accelerated approval program, Droxidopa (Northera) has proven to be effectual for relieving short term dizziness and hypotension in patients with Parkinson’s disease.  While there is a slight risk of supine hypertension for patients who take Droxidopa, studies have shown that patients who sleep with both their head and upper body elevated reduce their risk of this rare hypertension immensely. Dose increases of Droxidopa necessitate extensive monitoring of patients to ensure their safety and lessen their risk of supine hypertension. Adverse effects were mild for the majority of patients who received Droxidopa, and included nausea, tiredness and headache.

Droxidopa was effective and tolerable when administered to patients during two clinical trials, with the results leading the FDA to approve the short term use of this drug. The participants in the two week trials reported feeling significantly less lightheaded, faint and dizzy after taking Droxidopa as compared to the participants who received a placebo. Droxidopa (Northera), which is marketed by Chelsea is the only therapy approved at this time to treat NOH. A multi-center, randomized, larger and longer study of Northera is underway, which is likely to reveal the long term safety and efficacy of this novel drug. This current recruitment is slated to include over 1,400 participants and may last for over five year’s duration.

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