ARTICLE | Clinical News

Northera data sends Chelsea north

September 21, 2010 12:47 AM UTC

Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) gained $0.67 (13%) to $5.73 on Monday after reporting that Northera droxidopa met the primary endpoint vs. placebo in the Phase III Study 301 trial to treat neurogenic orthostatic hypotension (NOH). The orally-available synthetic precursor of norepinephrine significantly reduced mean composite Orthostatic Hypotension Questionnaire scores from randomization to day seven vs. placebo in 160 patients in the modified intent-to-treat (mITT) population. Chelsea plans to begin submission of a rolling NDA to FDA for Northera to treat NOH in 1H11 and complete the submission by 3Q11. ...