Chelsea reports top-line data from Phase III NORTHERA extension study in NOH

Jan 20 2011

• Patients Continue to Report Statistically Significant 2.8 Unit Improvement in OHQ Composite Scores Following 12 Months of Open Label Treatment With Northera (p<0.001)
• Parkinson's Disease Patients Maintain 50% Improvement (p<0.001) in Signs and Symptoms of Neurogenic Orthostatic Hypotension After One Year of Treatment With Northera
• Patients Treated With Northera Consistently Demonstrated Greater Than 12 mmHg Improvement in Standing Systolic Blood Pressure After One-Year Treatment Period (p<0.01)

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) reported new 12-month data from Study 303, a safety extension study from its Phase III NORTHERA™ (droxidopa) registration program in symptomatic neurogenic orthostatic hypotension (NOH). Preliminary, top-line results demonstrate Northera provides clinically meaningful and durable symptomatic improvements in patients with NOH throughout a one-year observation period. The data also validate that the drug is safe and well tolerated following extended dosing up to two years.

In May of 2010, Chelsea reported preliminary data from the first 75 patients to complete three months of treatment with Northera. That data demonstrated patients taking Northera reported a mean decrease of 3.2 units in their Orthostatic Hypotension Questionnaire (OHQ) composite score (p<0.001), representing a greater than 50% reduction in the signs and symptoms of NOH when compared with baseline, established prior to drug treatment. In addition, blood pressure assessments supported the strong symptomatic benefit in patients taking Northera, as patients treated for three months showed a statistically significant (p<0.001) mean improvement of 13.4 mmHg in standing systolic blood pressure (SBP) compared with baseline.

Following the initial three-month evaluation, patients were eligible to continue receiving Northera and were subsequently evaluated for efficacy after six and 12 months of continuous treatment. At the conclusion of the study, a total of 102 patients had received treatment with Northera in Study 303 with 2 patients reaching 24 months of treatment, 14 reaching 18 months, 55 patients reaching at least 12 months, and 63 patients treated for at least 6 months.