FDA Panel Will Weigh Northera’s Short-Term Benefit Vs. Lack Of Durable Effect, Safety Concerns

At its Feb. 23 review of Chelsea Therapeutics’ investigational orthostatic hypotension drug droxidopa, FDA’s Cardiovascular and Renal Drugs Advisory Committee will be asked to discuss sufficiency of the short-term efficacy data, clinical meaningfulness of the effect size and safety issues, including Japanese post-marketing reports of neuroleptic malignant syndrome.