Chelsea Therapeutics resubmits NDA for Northera to the US FDA

US biotech firm Chelsea Therapeutics (Nasdaq: CHTP) has resubmitted a New Drug Application to the US Food and Drug Administration to market Northera (droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension (NOH). It is intended for use in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.

The NDA resubmission includes data from Study 306B, a large Phase III study which confirms findings from Study 301 demonstrating improvement in dizziness/lightheadedness, the cardinal symptom of NOH. The FDA is expected to review and act on the NDA six months from the date of resubmission.

There was disappointment for the company in July last year when it received a written response from the FDA to the company’s modified proposal for utilizing data from ongoing Study 306B to support its Northera application. The FDA advised Chelsea to design and conduct an additional trial to support its evidence causing its shares to tumble 51% to $0.71 ( The Pharma Letter July 4 2012). But in February this year it wrote again to Chelsea to say that Study 306B had the potential to serve as the basis for an NDA resubmission causing its shares to soar to $1.61 ( TPL February 21). Shares have risen to $2.42 over the last few months.