Droxidopa capsules (marketed as Northera) have been granted accelerated approval to treat symptoms of neurogenic orthostatic hypotension, a rare, chronic and often debilitating drop in blood pressure upon standing associated with Parkinson disease, multiple-system atrophy, and pure autonomic failure, the FDA announced on Tuesday.
Approval was based on two clinical trials in which patients who took droxidopa for 2 weeks experienced decreased symptoms (e.g., dizziness, lightheadedness, feeling faint) compared with those on placebo. The most common side effects included headache, dizziness, and nausea.
The drug will carry a boxed warning about the increased risk for hypertension in the supine position; patients must be reminded to sleep with their heads and upper bodies elevated. Additionally, supine blood pressure should be monitored prior to and during treatment.
In January, an FDA advisory panel voted to grant approval for droxidopa, calling the decision “complex” due to questions about the drug’s efficacy.