Ema
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The FDA has approved droxidopa (Northera) for the treatment of neurogenic orthostatic hypotension, a rare disease that results in a drop in blood pressure when patients try to stand up.
The drug was passed up for approval 2 years ago when the FDA asked for more data from an additional clinical trial.
Approval stems from two clinical trials, each 2 weeks long, in which patients on droxidopa reported less dizziness, lightheadedness, feeling faint, or feeling as if they might black out than those on placebo.
The FDA noted, however, that the drug was OK'd under its accelerated approval program, which allows it to go on-market for demonstrating an effect on an "intermediate clinical measure" -- in this case, short-term relief of dizziness.
http://www.medpagetoday.com/Endocrinology/GeneralEndocrinology/44374
The drug was passed up for approval 2 years ago when the FDA asked for more data from an additional clinical trial.
Approval stems from two clinical trials, each 2 weeks long, in which patients on droxidopa reported less dizziness, lightheadedness, feeling faint, or feeling as if they might black out than those on placebo.
The FDA noted, however, that the drug was OK'd under its accelerated approval program, which allows it to go on-market for demonstrating an effect on an "intermediate clinical measure" -- in this case, short-term relief of dizziness.
http://www.medpagetoday.com/Endocrinology/GeneralEndocrinology/44374