Chelsea Therapeutics Announces Results from Northera Study

Chelsea Therapeutics International, Ltd.

today announced results from a study of Northera™ (droxidopa) in hypotensive individuals with spinal cord injury at the 23^rd International Symposium on the Autonomic Nervous System, which took place October 31 through November 3, 2012 in Paradise Island, Bahamas. The poster, titled "Blood Pressure Effect of Droxidopa in Hypotensive Individuals with Spinal Cord Injury," (poster #62) highlighted results of a clinical study designed to determine the blood pressure effect of escalating doses of droxidopa (100 mg, 200 mg & 400 mg) during three laboratory visits in hypotensive subjects (n=10) with spinal cord injury (SCI). The level of SCI ranged from cervical to low thoracic lesions, all were chronically injured and non-ambulatory and 8 were motor complete. Subjects were hypotensive at baseline (systolic BP: 87±14 mmHg; diastolic BP: 54±8 mmHg), and baseline BP did not differ among the 3 visits. Upon supine repositioning prior to drug administration, BP increased significantly (SBP: 101±11 mmHg; DBP: 62±7 mmHg; p<0.0001 versus seated baseline), regardless of dose, droxidopa did not augment the increase in BP upon supine repositioning. Seated BP was significantly increased from baseline after droxidopa in a dose-dependent manner (100 mg: 94±14/61±8 mmHg; 200 mg: 99±15/62±9 mmHg; 400 mg: 106±16/58±9 mmHg; p<0.0001). Although the elevation in seated BP was relatively modest, average 4-hour seated SBP & DBP were significantly increased with 400 mg droxidopa compared to 100 mg (p<0.001) and 200 mg (p<0.05).  "These preliminary data indicate that droxidopa increases seated BP in a dose-dependent manner without worsening supine increases in BP in hypotensive persons with SCI, suggesting a greater normalization of pressure across positional changes," said lead author Jill M. Wecht, Ed.D, Associate Professor of Medicine and Rehabilitation Medicine, the Mount Sinai School of Medicine. "Increasing seated blood pressure is an important clinical outcome in these individuals, because hypotension has been linked to deficits in memory and attention processing in the general population and in individuals with SCI. Further study of droxidopa is warranted in the SCI population."