Chelsea to re-file Northera at FDA for Symptomatic Neurogenic Orthostatic Hypotension

Chelsea Therapeutics International, Ltd. has received written guidance from the Director of the Office of New Drugs at the FDA stating that Study 306B has the potential to serve as the basis for a resubmission of a Northera (droxidopa) New Drug Application (NDA) for the treatment of Symptomatic Neurogenic Orthostatic Hypotension (NOH). The guidance suggests that "data strongly demonstrating a short-term clinical benefit (e.g., improvement in symptoms or ability to function) of droxidopa in patients with NOH would be adequate for approval, with a possible requirement to verify durable clinical benefit post-approval".

Based on this guidance, Chelsea plans to file a resubmission of the Northera NDA with the DCRP in the late second quarter of 2013. If accepted by the Division, the Company's application will be subject to a 6-month review period.