Findings from Study 305 evaluating the effect of Northera reported

Mar 18 2010

• Northera Effectively Increases SBP in Patients With Neurogenic Orthostatic Hypotension
• Patients Showed Mean Diurnal Increase of 8.4 mmHg SBP and Mean Nocturnal Increase of 7.8 mmHg SBP While on Northera

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) reported findings from Study 305, a study evaluating the effect of Northera™ (Droxidopa), an investigational agent being studied for the treatment of neurogenic orthostatic hypotension (NOH), on patients' 24-hour blood pressure (BP) profile.

Study 305 evaluated the blood pressure effects of Northera by comparing two 24-hour continuous BP monitoring periods in 18 patients with symptomatic NOH enrolled in Chelsea's ongoing Phase III Study 301. Blood pressure readings were initially recorded for 24 consecutive hours while patients were off drug during the washout phase of Study 301. These were then compared to similar readings recorded following Study 301 while patients were on active drug treatment during open-label extension studies.

Data from this study indicate that Northera treatment resulted in a consistent and expected increase in systolic BP (SBP) with patients experiencing a mean increase in average SBP of 7.3 mmHg over 24 hours while on drug (p<0.05). Notably, a comparative analysis of diurnal and nocturnal BP profiles on and off drug shows that the therapeutically relevant daytime SBP demonstrated a statistically significant mean increase of 8.4 mmHg (p<0.05). During the overnight hours, when blood pressure typically increases in NOH patients, Northera demonstrated less of an effect on SBP with a mean increase in average nocturnal SBP of 7.8 mmHg. In addition, no patients were observed to have consecutive SBP measurements > 180 mmHg for more than 3.5 hours at any time during the study. Consecutive nocturnal SBP measurements > 180 mmHg lasting 3.5 hours or less were observed in only 2 patients on drug treatment and 1 patient while off drug treatment. No serious adverse events were reported during the conduct of this study.

"That treatment of neurogenic orthostatic hypotension with Northera resulted in consistent improvements in blood pressure during the 24 hour treatment period without showing evidence of sustained high levels during the night is remarkable and strongly supportive of the safety of this novel investigational therapy," commented Dr. William Schwieterman, Chelsea Therapeutics' Chief Medical Officer. "As a whole, patients with NOH are inherently prone to significant variation and elevation of supine blood pressure as a consequence of their condition even when not receiving drug treatment. This is especially true at night when patients are constantly supine. Our data show that Northera appears uniquely able to meet the dual goals of selectively targeting and elevating overall blood pressure to drive symptomatic improvement during the day, without significant prolonged elevations in night time blood pressure."