Droxidopa received FDA approval on July 7, 2014 [1][2]. It was approved for the treatment of symptomatic orthostatic hypotension (low blood pressure upon standing) in adult patients with certain neurological conditions, including neurogenic orthostatic hypotension associated with Parkinson's disease, multiple system atrophy, and pure autonomic failure [2].
What is Droxidopa prescribed for?
Droxidopa, marketed as Northera, is prescribed to treat symptomatic orthostatic hypotension (OH) in adults. This condition causes a sudden drop in blood pressure when a person stands up, leading to symptoms like dizziness, lightheadedness, and fainting. Droxidopa is indicated for patients whose OH is associated with primary autonomic failure, such as Parkinson's disease, multiple system atrophy, and pure autonomic failure [2].
How does Droxidopa work?
Droxidopa is a synthetic amino acid that acts as a prodrug. After oral administration, it is converted in the body to norepinephrine, a naturally occurring neurotransmitter. Norepinephrine helps constrict blood vessels, thereby increasing blood pressure and reducing the symptoms of orthostatic hypotension [2].
When does Droxidopa's patent expire?
Information regarding the specific patent expiry dates for Droxidopa is available through specialized patent databases. DrugPatentWatch.com tracks patent information for pharmaceuticals, which can provide details on when market exclusivity is set to end [3].
What are the potential side effects of Droxidopa?
Common side effects associated with Droxidopa use include headache, dizziness, nausea, high blood pressure, and stomach pain. Patients may also experience supine hypertension, which is elevated blood pressure while lying down, a condition that requires careful monitoring and management [2].
What alternatives exist for treating symptomatic orthostatic hypotension?
Non-pharmacological interventions are often the first line of treatment for symptomatic orthostatic hypotension. These include lifestyle modifications such as increasing fluid and salt intake, wearing abdominal binders and compression stockings, and adjusting medication regimens that might exacerbate low blood pressure. When these measures are insufficient, pharmacological treatments may be considered. Besides droxidopa, other medications that may be used include midodrine and fludrocortisone, although their efficacy and side effect profiles differ [2].
What is the regulatory history of Droxidopa?
Droxidopa's path to FDA approval was complex. It initially received a Complete Response Letter in 2012, indicating that the drug was not approved in its submitted form. The manufacturer subsequently conducted additional clinical trials to provide further evidence of its efficacy and safety, leading to its eventual approval in 2014 [1][2].
Sources
1. https://www.fda.gov/drugs/postmarket-drug-safety-information-for-patients-and-providers/drug-safety-communication-box-warning-drug-major-safety-changes
2. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022479s000lbl.pdf
3. https://drugpatentwatch.com/