The U.S. Food and Drug Administration today approved Chelsea Therapeutics CHTP 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.
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