The U.S. Food and Drug Administration today approved Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension (NOH). NOH is a rare, chronic and often debilitating drop in blood pressure upon standing that is associated with Parkinson's disease, multiple-system atrophy, and pure autonomic failure.
Symptoms of NOH include dizziness, lightheadedness, blurred vision, fatigue and fainting when a person stands.
“People with neurogenic orthostatic hypotension are often severely limited in their ability to perform routine daily activities that require walking or standing,” said Norman Stockbridge, M.D., Ph.D, director of the Division of Cardiovascular and Renal Drugs in the FDA's Center for Drug Evaluation and Research. “There are limited treatment options for people with NOH and we are committed to helping make safe and effective treatments available.”
The FDA is approving Northera under the accelerated approval program, which allows for approval of a drug to treat a serious disease based on clinical data showing that the drug has an effect on an intermediate clinical measure (in this case, short-term relief of dizziness) that is reasonably likely to predict the outcome of ultimate interest (relief of dizziness during chronic treatment). This program provides patient access to promising drugs while the company conducts post-approval clinical trials to verify the drug's clinical benefit, which for this approval is a long-term effect on patient symptoms in NOH, a chronic disease.
Northera has a boxed warning to alert health care professionals and patients about the risk of increased blood pressure while lying down (supine hypertension), a common problem that affects people with primary autonomic failure and can cause stroke. It is essential that patients be reminded that they must sleep with their head and upper body elevated. Supine blood pressure should be monitored prior to and during treatment and more frequently when increasing doses.
The most common adverse events reported by clinical trial participants taking Northera were headache, dizziness, nausea, high blood pressure (hypertension) and fatigue.
The effectiveness of Northera was shown through two-weeks in two clinical trials in people with NOH. People taking Northera reported a decrease in dizziness, lightheadedness, feeling faint, or feeling as if they might black out compared to those taking an inactive pill (placebo). Durability of the improvement in patient symptoms beyond two weeks has not been demonstrated.
Northera received orphan-product designation from the FDA because it is intended to treat a rare disease or condition.
Northera is made by Charlotte-based Chelsea Therapeutics Inc.
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SOURCE: February 18, 2014