The US Food and Drug Administration (FDA) today approved droxidopa (Northera, Chelsea Therapeutics) for the treatment of neurogenic orthostatic hypotension (NOH) that is associated with Parkinson's disease, multiple-system atrophy, and pure autonomic failure.
The green light follows a 16-1 vote last month in favor of approval of droxidopa for NOH from the FDA's Cardiovascular and Renal Drugs Advisory Committee, despite their concerns about lack of evidence of long-term durability, as reported previously by Medscape Medical News .
The Committee first considered droxidopa for NOH in February 2012, and voted in a close vote of 7 to 4 in favor of approval. The FDA declined approval, though, in March 2012, suggesting the drug needed more study.
"People with neurogenic orthostatic hypotension are often severely limited in their ability to perform routine daily activities that require walking or standing," Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Drugs in the FDA's Center for Drug Evaluation and Research, said in an FDA statement released today.
"There are limited treatment options for people with NOH and we are committed to helping make safe and effective treatments available," Dr. Stockbridge added.
Droxidopa is converted in the body to norepinephrine. It is only the second drug approved for NOH in the United States; the other is the vasoconstrictor midodrine.
The FDA notes that the effectiveness of droxidopa was shown through 2 weeks in 2 clinical trials in patients with NOH. Patients taking droxidopa reported a decrease in dizziness, lightheadedness, feeling faint, or feeling as if they might black out compared with those taking a placebo, the FDA said.
"Durability of the improvement in patient symptoms beyond 2 weeks has not been demonstrated," the agency notes.
The most common adverse events reported by clinical trial participants taking droxidopa were headache, dizziness, nausea, hypertension, and fatigue.
The FDA says droxidopa will carry a boxed warning about the risk for supine hypertension. "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 FDA advises.
The FDA approved droxidopa 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 postapproval 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.
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Cite this: FDA Clears Droxidopa for Neurogenic Orthostatic Hypotension - Medscape - Feb 18, 2014.