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November 21, 2011

FDA accepts new drug application for Northera

Chelsea Therapeutics has received US Food and Drug Administration (FDA) acceptance for the filing of a new drug application for Northera (droxidopa), designed to treat symptomatic neurogenic orthostatic hypotension.

Chelsea Therapeutics has received US Food and Drug Administration (FDA) acceptance for the filing of a new drug application for Northera (droxidopa), designed to treat symptomatic neurogenic orthostatic hypotension.

Northera, a synthetic catecholamine, will increase the levels of norepinephrine, both centrally and peripherally.

In previous Phase II trials, Northera has demonstrated clinical benefits in treating both intradialytic hypotension and adult attention deficit hyperactivity disorder, and is now being evaluated in an ongoing Phase II trial for the treatment of fibromyalgia.

As per the Prescription Drug User Fee Act, the FDA will review and act on the application by 28 March 2012.

Chelsea Therapeutics president and CEO Simon Pedder said the Phase III data demonstrates the safety and efficacy of Northera for the treatment of neurogenic orthostatic hypotension.

"We are pleased with the FDA’s acceptance of our new drug application for Northera and its decision to grant it priority review, as it brings us one step closer to offering the first treatment that specifically improves symptoms of neurogenic orthostatic hypotension and reduces their impact on a patient’s ability to perform daily activities," Pedder said.

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