FDA Approves Multiple Sclerosis Drug
Ampyra (dalfampridine), a multiple sclerosis (MS) drug that helps improve the walking ability of adults suffering from the condition has been given approval by the US Food and Drug Administration
(FDA).
Over three-fourths of MS patients have difficulty walking, called the most challenging aspect of the disease by 70% of them.
The National Multiple Sclerosis Society defines MS as a ‘chronic disease leading to disability as it attacks the central nervous system made up of the brain, spinal cord and optic nerves. MS symptoms include extreme fatigue, difficulty walking, problems with memory and heat sensitivity.
Andrew D. Goodman, MD, who led some of the clinical trials leading to the drug’s approval says, Ampyra does not prevent MS from getting worse, but is to be taken along with other drugs for MS.
It has been found to help 35% in one study and 42% in another to walk faster, while there is a 25% baseline improvement in those who cannot walk faster, as they are able to walk longer distances, remain on their feet longer, climb stairs better, including performing other walking functions better.
Without changing the course of the MS, Ampyra enhances nerve function, slowing the progressive nature of the disease process.
However, there are side-effects to the drug as it is a new formulation of fampridine, a drug originally used as a bird poison. Test tube studies, some 20-years ago suggested fampridine improved nerve conduction, leading to some neurologists ordering the drug for their MS patients.
If, higher doses than the approved 10 milligrams twice daily dose are taken, Ampyra causes seizures, which means MS patients who have a history of seizure or those with moderate-to-severe kidney disease cannot use the drug, which also cannot be taken with other forms of fampridine.
Side effects of the drug in clinical trials include insomnia, urinary tract infection, headache, dizziness, back pain, nausea, balance disorder, loss of muscle strength, tingling or numbness, multiple sclerosis relapse, nose or throat inflammation, upset stomach, constipation and throat pain.
Manufactured by Acorda Therapeutics of Hawthorne, N. Y., Ampyra will be available in in March, sold through specialty pharmacies co-ordinated by Ampyra Support Services at 888-881-1918.
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