- 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
CHARLOTTE, N.C., March 17, 2010 (GLOBE NEWSWIRE) -- 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."
Dr. William Schwieterman will present these results during his presentation at the ROTH 21st Annual OC Growth Stock Conference today at 11:00 AM PT at The Ritz-Carlton, Laguna Niguel. Dr. Schwieterman's presentation will be webcast live and archived for 90 days on Chelsea's website, www.chelseatherapeutics.com.
About Neurogenic Orthostatic Hypotension
NOH is a neurogenic disorder resulting from deficient release of norepinephrine, the neurotransmitter used by sympathetic autonomic nerves to send signals to the blood vessels and the heart to regulate blood pressure. This deficiency results in decreased blood pressure when a person assumes a standing position and is characterized by lightheadedness, dizziness, and syncope. Symptoms of chronic NOH can be incapacitating -- not only putting patients at high risk for falls and associated injuries and generating significant health care costs -- but also severely affecting the quality of life of patients and their loved ones. The only FDA-approved treatment for orthostatic hypotension has a black box warning indicating that the drug has not been shown to be effective in alleviating the symptoms of the condition and is associated with a pronounced side-effect profile including significant supine hypertension.
About Northera™
Northera (Droxidopa), the lead investigational agent in Chelsea Therapeutics' broad pipeline, is currently in Phase III clinical trials for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure – a group of diseases that includes Parkinson's disease, multiple system atrophy (MSA) and pure autonomic failure (PAF). Droxidopa is a synthetic catecholamine that is directly converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE in the nervous system, both centrally and peripherally. Droxidopa is also being studied for the treatment of fibromyalgia in an ongoing phase II trial and completed a phase II trial in intradialytic hypotension (IDH) study with positive results.
About Chelsea Therapeutics
Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases. Chelsea's most advanced drug candidate, Droxidopa, is an orally active synthetic precursor of norepinephrine initially being developed for the treatment of neurogenic orthostatic hypotension. In addition to Droxidopa, Chelsea is also developing a portfolio of metabolically inert oral antifolate molecules engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders, including two clinical stage product candidates: CH-1504 and CH-4051. Preclinical and clinical data suggest superior safety and tolerability, as well as increased potency versus methotrexate (MTX).
This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include our need to raise operating capital, our history of losses, risks and costs of drug development, risk of regulatory approvals, our reliance on our lead drug candidates Droxidopa and CH-4051, reliance on collaborations and licenses, intellectual property risks, competition, market acceptance for our products if any are approved for marketing and reliance on key personnel including specifically Dr. Pedder.