Jan 10 A treatment developed by Chelsea
Therapeutics International Ltd for a rare type of low
blood pressure is presenting problems for U.S. drug reviewers at
the U.S. Food and Drug Administration.
A review, posted on the FDA's website on Friday, comes
ahead of a meeting on Jan. 14 of outside medical experts who
will discuss the drug and recommend whether it should be
approved. The FDA generally follows the advice of its advisory
The drug, droxidopa, is designed to treat neurogenic
orthostatic hypotension (NOH), a rare, chronic type of low blood
pressure that occurs on standing.
Arguments in favor of approval include "strong evidence"
that the drug confers at least one week of benefit, the staff
review found. Arguments against approval include a lack of
evidence that the benefit is durable over a longer period of
The disorder is associated with certain neurological
disorders such as Parkinson's disease; multiple system atrophy;
and pure autonomic failure -- conditions which can impair the
body's involuntary functions such as blood pressure and heart