Chelsea Therapeutics announced that the first patient has been dosed in Study 401, a multi-center, multi-national, randomized, parallel-group, placebo-controlled, double-blind study of investigational drug NORTHERA, an orally active synthetic precursor of norepinephrine, being studied for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure, dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy. The company expects Study 401 to enroll approximately 450 patients. Chelsea Therapeutics is currently seeking approval from the U.S. Food and Drug Administration to market Northera for the treatment of symptomatic nOH in adult patients with primary autonomic failure, non-diabetic autonomic neuropathy and dopamine-beta-hydroxylase deficiency. The company's New Drug Application is scheduled for review by the Cardiovascular and Renal Drug Advisory Committee on January 14, 2014, with a Prescription Drug User Fee Act target date of February 14, 2014.
- Health Care Industry