On Thursday, Feb 23, 2012, the FDA Cardiovascular and Renal Drugs Advisory Committee will meet to discuss Chelsea Therapeutics NORTHERA (droxidopa) NDA for use in the treatment of some very specific aspects of orthostatic hypotension. Chelsea asked for and was granted Orphan Drug designation.
The drug seems to have a positive short term effect but there are a lot of serious concerns about safety, both from data that have been reported in the clinical trials and from post marketing reports from Japan where it is approved although at a lower dose. At least equally important to making a decision are the unanswered questions about efficacy and safety. The FDA has listed the known problems as well as the deficiencies in the data base in their briefing document and conclude that the drug is not ready for approval.
The Advisory Committee will likely agree with the FDA conclusion on this drug.