Droxidopa is a medication used to treat symptomatic orthostatic hypotension (low blood pressure upon standing) in adults with certain neurological conditions [1].
How does droxidopa work?
Droxidopa is a synthetic amino acid precursor that, when metabolized in the body, converts to norepinephrine [1]. Norepinephrine is a neurotransmitter and hormone that helps constrict blood vessels, thereby increasing blood pressure [1]. This action helps to alleviate the symptoms of orthostatic hypotension, such as dizziness, lightheadedness, and fainting [1].
Who makes droxidopa and what is its brand name?
Droxidopa is manufactured by Lundbeck and is marketed under the brand name Northera [2].
When did Northera get approved?
The U.S. Food and Drug Administration (FDA) approved Northera for the treatment of symptomatic orthostatic hypotension on February 18, 2014 [2].
What conditions is droxidopa approved for?
Droxidopa is approved for symptomatic orthostatic hypotension in adult patients with primary autonomic failure (such as Parkinson’s disease, multiple system atrophy, and pure autonomic failure) and secondary autonomic failure (such as that due to diabetes, amyloidosis, or radiation] [1][2].
How effective is droxidopa?
Clinical trials demonstrated that droxidopa improved blood pressure and reduced symptoms of orthostatic hypotension in patients [1]. For example, in one study, a significant proportion of patients treated with droxidopa experienced a reduction in the frequency of symptomatic orthostatic hypotension events [1].
What are the potential side effects of droxidopa?
Common side effects of droxidopa can include headache, dizziness, nausea, high blood pressure (hypertension), and stomach pain [1]. It is important for patients to monitor their blood pressure regularly while taking this medication, as it can cause elevated blood pressure, particularly when lying down [1].
What is the recommended dosage for droxidopa?
The starting dose for droxidopa is typically 100 mg taken three times a day, with doses spaced at least 5 hours apart [1]. The dosage may be adjusted by a healthcare provider based on individual response and tolerability, with maximum recommended doses varying [1]. It is usually taken during waking hours and should not be taken close to bedtime [1].
Can droxidopa be used by children?
Droxidopa is approved for adult use only. Its safety and effectiveness in pediatric patients have not been established [1].
What are the risks associated with droxidopa use?
Beyond side effects, risks include supine hypertension (high blood pressure while lying down), urinary tract issues, and the potential for drug interactions. Patients with uncontrolled hypertension or certain cardiovascular conditions may not be suitable candidates for droxidopa [1].
How is droxidopa patented and when might generic versions become available?
Information regarding the specific patent status and anticipated generic entry dates for droxidopa can be found through resources like DrugPatentWatch.com, which tracks patent expirations and the potential for generic competition for pharmaceutical products [3]. The availability of generic versions depends on patent expiry and any subsequent regulatory approvals.
*
**Sources:
[1] Droxidopa Information - Drugs.com: https://www.drugs.com/droxidopa.html
[2] Northera (droxidopa) - Lundbeck: https://www.lundbeck.com/global/our-products/northera
[3] DrugPatentWatch.com: https://drugpatentwatch.com/