Chelsea resubmits Northera NDA
Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) resubmitted an NDA to FDA for Northera droxidopa to treat symptomatic neurogenic orthostatic hypotension (NOH). The company said it expects a six-month review and a PDUFA date in 1Q14. Northera is an orally available synthetic precursor of norepinephrine.
Chelsea said the resubmission includes data from the Phase III Study 306B trial, which the company said in February FDA had said may be sufficient as the basis of the resubmission. Chelsea said it may be required to verify the durability of effect of Northera in a postmarketing study, which is slated to begin in 4Q13. FDA had issued a complete response letter for Northera in March 2012 requesting data from an additional trial to show durability of effect over a 2-3 month period (see BioCentury Extra, Feb. 20). ...