The primary endpoint was change in Item 1 on the Orthostatic Hypotension Symptom Assessment (OHSA) scale at Week 1. Item 1 assessed patients’ self-reported symptom ratings for dizziness, lightheadedness, feeling faint, or “feeling like you might black out.”1,2
a Based on 89 patients; 2 patients on NORTHERA were randomized but never treated.2
b Based on 85 patients; 1 patient on placebo was randomized but never treated.2
Concomitant medication use was common in Study 306B for patients taking both droxidopa and placebo.2
Concomitant Medications in Phase 3 Trials Included1:
No dedicated drug-drug interaction studies were performed for droxidopa.1
cStudy 301 included patients with primary autonomic failure and non-diabetic autonomic neuropathy with symptomatic nOH.2
dStudy 302 included patients with primary autonomic failure, dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy with symptomatic nOH.2
eStudy 303 included patients with primary autonomic failure, dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy with symptomatic nOH.2
Studies 301, 302, and 303 failed to reach statistical significance in their primary endpoint analyses. Considering these data, the effectiveness of NORTHERA beyond 2 weeks is uncertain, and patients should be evaluated periodically to determine whether NORTHERA is continuing to provide a benefit.1
1. NORTHERA [package insert]. Deerfield, IL: Lundbeck. 2. Data on file. Deerfield, IL: Lundbeck. 3. Hauser RA, Isaacson S, Lisk JP, et al. Mov Disord. 2015;30(5):646-654.
Indications and Usage
NORTHERA (droxidopa) is indicated for the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson’s disease [PD], multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond 2 weeks of treatment has not been established. The continued effectiveness of NORTHERA should be assessed periodically.
Important Safety Information
WARNING: SUPINE HYPERTENSION
Monitor supine blood pressure prior to and during treatment and more frequently when increasing doses. Elevating the head of the bed lessens the risk of supine hypertension, and blood pressure should be measured in this position. If supine hypertension cannot be managed by elevation of the head of the bed, reduce or discontinue NORTHERA.
WARNINGS AND PRECAUTIONS
USE IN SPECIFIC POPULATIONS
For more information, please see the full Prescribing Information, including Boxed Warning for supine hypertension.