The drug is the first and only therapy approved by the FDA, which demonstrates symptomatic benefit in patients with NOH.
NOH is 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.
The FDA is approving the drug under the accelerated approval program, which allows for conditional approval of a drug to treat a serious disease based on clinical data showing that the drug has an effect on an intermediate clinical measure.
A multi-center, placebo-controlled, randomized trial, 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 about 1,400 patients, which the FDA has agreed may be enrolled over a six year period.
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, Chelsea received the exclusive rights and licenses to develop and commercialise droxidopa worldwide excluding Japan, Korea, China and Taiwan from Dainippon Sumitomo Pharma (DSP).
Symptomatic NOH is an autonomic nervous system disorder caused by failure to produce and or release sufficient amounts of norepinephrine upon standing.