FDA issues Northera complete response

FDA issued a complete response letter for an NDA for Northera droxidopa from Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) to treat symptomatic neurogenic orthostatic hypotension (NOH). According to Chelsea, FDA requested data from an additional trial to show durability of effect over a 2-3 month period and support data from the Phase III Study 301 trial. Chelsea said it believes data from the Phase III Study 306 trial, which is evaluating Northera to treat symptomatic NOH associated with Parkinson's disease, could potentially meet FDA's criteria for clinical efficacy and durability of effect.

According to the company, FDA made a preliminary recommendation to include a black box warning related to supine hypertension, though the agency indicated a boxed warning could be reconsidered if data are provided to show a lack of severe hypertension in a fully prone position vs. a 30-degree head-up tilt. Chelsea plans to request a meeting with FDA to discuss the letter. ...