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US stock market daily report (February 19, 2014, Wednesday)
Chelsea Therapeutics International Ltd. (CHTP-Nasdaq) received approval Tuesday, from the U.S. Food and Drug Administration for Northera capsules (droxidopa) to be used for the treatment of neurogenic orthostatic hypotension (NOH). Northera received orphan-drug designation from the FDA because it is intended to treat a rare disease or condition.
NOH is a rare, chronic and often debilitating drop in blood pressure upon standing, associated with Parkinson's disease, multiple-system atrophy, and pure autonomic failure. Symptoms of NOH include dizziness, lightheadedness, blurred vision, fatigue and fainting when a person stands.
Northera was approved under the FDA accelerated approval program which allows for approval of a drug to treat a serious disease based on clinical data showing that the drug has an effect on an intermediate clinical measure (in this case, short-term relief of dizziness) that is reasonably likely to predict the outcome of ultimate interest (relief of dizziness during chronic treatment). The FDA AAP provides patient access to promising drugs while the pharmaceutical firm conducts post-approval clinical trials to verify the clinical benefit for the drug. For NOH, long-term effects on patient symptoms with the chronic disease, will be closely monitored. Per clinical trials for Northera, the most adverse side effects patients experienced were headache, dizziness, nausea, high blood pressure (hypertension) and fatigue.
During two clinical trials of two weeks each, patients taking Northera reported a decrease in dizziness, lightheadedness, feeling faint or feeling as if they might black out compared to those taking placebo. Durability of the improvement in patient symptoms beyond two weeks has not been demonstrated.
A boxed warning for Northera will alert health care professionals and patients about the risk of increased blood pressure while lying down (supine hypertension), which is a common issue that affects people with primary autonomic failure and can result in a stroke. Patients are reminded of the dire importance that when they lie down or sleep, they must do so with their head and upper body elevated. Supine blood pressure should be monitored prior to and during treatment with Northera, as well as an increased frequency of monitoring the patient when there is an increase of the prescribed dose.
Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research said, “People with neurogenic orthostatic hypotension are often severely limited in their ability to perform routine daily activities that require walking or standing. There are limited treatment options for people with NOH and we are committed to helping make safe and effective treatments available.”
Chelsea shares were higher by 24% into mid-day trading Wednesday.
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