Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Chelsea Therapeutics has filed a new drug application (NDA) with the US Food and Drug Administration (FDA) to market Northera (droxidopa).
Subscribe to our email newsletter
Northera is indicated as a treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure, dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.
The NDA filing is backed by the combined safety and efficacy data from Chelsea’s two completed Phase III efficacy studies in NOH (Studies 301 and 302).
Chelsea president and CEO Simon Pedder said they believe the clinical data generated by their Phase III program clearly demonstrates that Northera is safe and effective for the treatment of symptomatic NOH.
"We look forward to working closely with FDA on this application while progressing other clinical studies currently underway for Northera and our phase II anti-inflammatory program with CH-4051," Pedder said.