ARTICLE | Clinical News

Northera droxidopa regulatory update

February 20, 2012 8:00 AM UTC

Chelsea unveiled details of FDA briefing documents the company received ahead of this month's advisory panel meeting to discuss an NDA for Northera droxidopa to treat symptomatic neurogenic orthostatic hypotension (NOH). According to Chelsea, the documents included questions about the "short duration" of Northera clinical studies, which "may not adequately establish a durable treatment effect"; the "limited" size of the study population; and the "challenges" in quantifying symptomatic and clinical benefit. ...