Northera droxidopa: Phase III started

Chelsea began the double-blind, placebo-controlled, international Phase III Study 401 to evaluate 100, 200 and 300 mg oral Northera for up to 17 weeks in about 450 symptomatic NOH patients with primary autonomic failure, dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy. Northera is under FDA review to treat symptomatic NOH, with a Feb. 14 PDUFA date; FDA's Cardiovascular and Renal Drug Advisory Committee is scheduled to meet on Jan. 14 to discuss the NDA. ...