CHARLOTTE, N.C. (TheStreet) -- Chelsea Therapeutics(CHTP) reported positive results Monday from a late-stage study of its experimental drug Northera in patients with neurogenic orthostatic hypotension, a disease characterized by a chronic drop in blood pressure upon standing.
The benefit of Northera demonstrated in this most recent phase III study comes after disappointing results from an earlier phase III study in October 2009. After that initial failure, Chelsea amended the design of the current phase III study with the permission of U.S. regulators.
Chelsea said treatment with Northera provided clinically meaningful and statistically significant improvement in symptoms associated with neurogenic orthostatic hypotension (NOH) compared to treatment with a placebo.
The study's primary endpoint was measured using a questionnaire specifically designed to rate the severity of symptoms resulting from low blood pressure and the degree those symptoms interfere with a patient's ability to perform activities of daily living.
"We are extremely excited by these top-line results which provide validation of the safety and efficacy of Northera as a novel treatment for symptomatic neurogenic orthostatic hypotension, a serious condition for which there is an urgent need for improved treatments," said Chelsea CEO Simon Pedder. "Symptoms of chronic neurogenic orthostatic hypotension are severe, not only putting patients at high risk for falls and associated injuries but also severely impacting their quality of life and generating significant added health care costs."
Chelsea said secondary endpoints in the Northera clinical trial were also met and that the drug was generally safe and well tolerated, with headaches the most common adverse event reported. No falls were reported in patients treated with Northera compared to three patient falls reported in the placebo arm.
Another phase III study of Northera in patients with NOH associated with Parkinson's disease is underway, with data expected in the second quarter of next year.
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