Chelsea Therapeutics Says First Patient Dosed In NORTHERA Study 401 -Quick Facts

(RTTNews) - Chelsea Therapeutics International, Ltd. (CHTP) said 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 to treat symptomatic neurogenic orthostatic hypotension or nOH in patients with primary autonomic failure, dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.

The Study 401, which is anticipated to enroll nearly 450 patients, would evaluate the clinical efficacy and safety of Northera versus placebo over a 17-week (maximum) treatment period consisting of an initial, open-label dose titration, followed by a washout period, followed by a 12-week treatment period on a stable dose.

The trial's primary outcome measure is to assess the duration of clinical benefit of Northera as demonstrated by the change in the Orthostatic Hypotension Symptom Assessment Item 1, including symptoms of dizziness and lightheadedness. Meanwhile, the secondary outcome measures include patient reported falls, standing blood pressure change, and other efficacy measures, including the orthostatic hypotension questionnaire composite and individual item scores and the clinical global impression scales, according to the company.

Currently, Chelsea is seeking approval from the U.S. Food and Drug Administration or FDA to market Northera for symptomatic nOH treatment in adult patients with primary autonomic failure, non-diabetic autonomic neuropathy and dopamine-beta-hydroxylase deficiency. The firm''s New Drug Application is slated 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.