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news.The US Food and Drug Administration (FDA) has approved the filing of New Drug Application (NDA) by Chelsea Therapeutics for its Northera (droxidopa) drug, used in the treatment of symptomatic neurogenic orthostatic hypotension (NOH).
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Northera, a synthetic catecholamine increases the levels of norepinephrine, both centrally and peripherally.
Previous Phase II trials demonstrated the efficacy of the drug in treating both intradialytic hypotension and adult attention deficit hyperactivity disorder.
Currently, Northera is now being evaluated in an ongoing Phase II trial for the treatment of fibromyalgia.
Chelsea Therapeutics president and CEO Simon Pedder said the Phase III data demonstrate the safety and efficacy of Northera for the treatment of NOH.
"We are pleased with the FDA’s acceptance of our NDA for Northera and their decision to grant it priority review, as it brings us one step closer to offering the first treatment that specifically improves symptoms of NOH and reduces their impact on a patient’s ability to perform daily activities," Pedder added.