Lundbeck reports positive data from new trials of Northera

Lundbeck has highlighted a responder analysis of data from two phase III clinical trials of its drug Northera, showing its efficacy in the treatment of symptomatic neurogenic orthostatic hypotension (nOH).

Data from 359 patients enrolled in two placebo-controlled trials was considered in the analysis. Study 301 involved adult patients with autonomic failure and symptomatic nOH, while study 306 enrolled adult patients with Parkinson’s disease and symptomatic nOH.

The analysis provided insight into an entire range of responses relative to placebo and helped to not only describe patients who had average benefits, but also those who had a better-than-average change in symptoms.

Approved in the US earlier this year, Northera is indicated for the treatment of orthostatic dizziness, lightheadedness or the feeling of being about to black out in adult patients with symptomatic nOH caused by primary autonomic failure.

Dr Horacio Kaufmann, one of the study’s co-authors, said: "When evaluated individually, both study 301 and 306 show that the average response to Northera is clinically meaningful."

Symptomatic nOH is a rare autonomic nervous system disorder, associated with a failure to produce or release adequate amounts of norepinephrine upon standing.