New responder data for Lundbeck's Northera for symptomatic neurogenic orthostatic hypotension

A responder analysis of data from two Phase III clinical trials evaluating Northera (droxidopa) for patients with symptomatic neurogenic orthostatic hypotension (nOH) was presented today at the 19th International Congress of Parkinson’s Disease and Movement Disorders.

Northera, a norepinephrine prodrug, was approved by the US Food and Drug Administration in February 2014, and is available across the USA through a specialty pharmacy. The drug was developed by Chelsea Therapeutics, which was acquired by Danish CNS specialist Lundbeck (LUND: CO) for $658 million last year.

The analysis included 359 patients from two placebo-controlled clinical trials: study 301, which enrolled adult patients with autonomic failure and symptomatic nOH, and study 306, which enrolled adult patients with Parkinson’s disease and symptomatic nOH. Symptom improvement was analyzed to determine the point at which there was a clinically meaningful change in dizziness, lightheadedness, feeling faint or ''feeling like you might black out.''