Chelsea to Conduct Further Trial to Show Effectiveness of Northera
It has been reported that the Food and Drug Administration of the US has asked the manufacturer of Northera, a low-blood-pressure medication to provide with more proves to show that the medication is effective in treating low-blood-pressure.
Following the revelation, the shares of Chelsea Therapeutics International Ltd. (CHTP) fell down significantly. The Food and Drug Administration has expressed doubts over the benefits of the medication.
Last month, the advisory committee of the Food and Drug Administration voted against the medication. Since then, the manufacturer has been in talks with the authorities. It has been informed that the controversial drug, Northera, is already being sold in Japan for past 20 years.
The Food and Drug Administration has said that the drug taken by patients for weeks doesn’t leaves effective effect on the patient health. The manufacturer has informed that the drug is capable of controlling the problem of low-blood-pressure for two or three months.
The Food and Drug Administration have also recommended of labeling on the medication package. The labeling, as recommended by the administration, should clearly highlight that a patient taking the drug would experience dizziness and lightheadedness.
Chelsea said that it would be working as per the guidelines of the authorities. The company has estimated that within five years of its sales, the firm can book revenue of 300 million to $375 million. However, it is yet not clear as to when the drug would be launched.
The company would be conducting yet another trial to show the effectiveness of the drug in treating low-blood-pressure. It has been informed that the drug has an orphan status. It means that the drug has the potential of treating a rare type of health problem which affects 200,000 Americans.
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