The US Food and Drug Administration has approved Ampyra (dalfampridine) extended release tablets to improve walking in patients with multiple sclerosis (MS). In clinical trials, patients treated with Ampyra had faster walking speeds than those treated with placebo. This is the first drug approved for this use.
“Trouble with walking is one of the most debilitating problems people with MS face,” said Russell Katz MD, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research.
Ampyra, 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 Ampyra in clinical trials include urinary tract infection, insomnia, dizziness, headache, nausea, weakness, back pain, balance disorder, swelling in the nose or throat, constipation, diarrhea, indigestion, throat pain, and burning, tingling or itching of skin.
Ampyra 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.
Ampyra will be manufactured under licenses from Elan of Dublin, Ireland, and distributed by Acorda Therapeutics Inc. of Hawthorne, New York.
Source: News Release
US Food and Drug Administration
January 22, 2010