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FDA Approves Dalfampridine to Improve Walking in Adults With MS ROCKVILLE, Md -- January 24, 2010 -- The US Food and Drug Administration (FDA) has approved dalfampridine (Ampyra) extended release tablets to improve walking in patients with multiple sclerosis (MS). In clinical trials, patients treated with dalfampridine had faster walking speeds than those treated with a placebo. “Trouble with walking is one of the most debilitating problems people with MS face,” said Russell Katz, MD, Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, Rockville, Maryland. Dalfampridine, when given at doses greater than that recommended (10 mg twice a day), can cause seizures. The most common adverse reactions reported by patients taking dalfampridine in clinical trials include urinary tract infection, insomnia, dizziness, headache, nausea, weakness, back pain, balance disorder, swelling in the nose or throat, constipation, diarrhoea, indigestion, throat pain, and burning, tingling or itching of skin. Dalfampridine should not be used in patients with moderate to severe kidney disease. In these patients, blood levels with the drug approach those associated with the occurrence of seizures. SOURCE: US Food and Drug Administration E-mail this page to a friend or colleague! To print, use this version