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FDA panel clears fampridine-SR
Thursday, October 15 2009 | Comments
What's This?
The Food and Drug Administration's Peripheral and Central Nervous System Drugs Advisory Committee voted 12-1 that fampridine sustained release (SR) at a dosage of 10 mg twice daily is effective for improving the ability to walk in patients with MS.The panel also voted 10-2, with one abstention, that the compound is clinically meaningful and safe for use.
The panelists, however, said the drug should not be used to treat individuals with seizures and recommended that lower doses of the drug be studied, Reuters reported. Acorda Therapeutics Inc., the drug's developer, noted that the committee voted 10-2, with one abstention, that these studies not be required before approval.
In documents released prior to the meeting, FDA staff said fampridine-SR had a very limited effect on walking speed in patients with MS in the 2 studies seen.
Although analyses of the drug-placebo difference regarding the change from baseline in the time to complete the 25-foot timed walk reached statistical significance in both studies, the reviewers said the difference was numerically quite small. Additionally, they noted that the average time to complete the 25-foot walk was not different between the treatment groups in either study.
A New Drug Application (NDA) was submitted to support the marketing of fampridine-SR as a treatment for the (symptomatic) improvement of walking ability in patients with MS. The action date for the NDA is Oct. 22.
FDA staff said this indication has never been granted before, as currently approved MS drugs are indicated to decrease relapse rate and, in some cases, to prevent the accumulation of disability.
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