FDA Identifies Technical Deficiencies In Chelsea's Resubmitted NDA For NORTHERA

(RTTNews) - Chelsea Therapeutics International, Ltd. (CHTP), Monday said that the US Food and Drug Administration or FDA has identified certain technical deficiencies in the resubmitted New Drug Application or NDA for NORTHERA. The FDA notified deficiencies with regard to the formatting of certain submitted electronic datasets and statistical programs describing the methods used to generate tables and listings, and the company said in a statement that the deficiencies are not related to study conduct, interpretability of study results, or validity of study conclusions.

The company believes to resolve the issues quickly, and anticipates submission of necessary response in August. Chelsea added that the FDA will not begin the six month review, unless it receives the response. After the resubmission with the changes looked by from the FDA, a new PDUFA date will be set by the Agency, the company said.

The company previously told on July 17, that it received written confirmation from the FDA that the resubmission was deemed to be a complete response to its March 28, 2012 Complete Response Letter and was assigned a new PDUFA date of January 3, 2014.

NORTHERA, an investigational agent, is currently in Phase III development for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure, an indication that includes a significant number of patients with Parkinson's disease, multiple system atrophy (MSA) and pure autonomic failure (PAF).