An extended release tablet designed to improve walking in multiple sclerosis sufferers has been approved for use by the US Food and Drug Administration.
Ampyra (dalfampridine) is the first drug approved for this use, and patients treated with it during clinical trials saw faster walking speeds than those taking an inactive placebo pill.
Russell Katz, director of the Division of Neurology Products at the FDA, said: “Trouble with walking is one of the most debilitating problems people with MS face.”
The most common adverse reactions to Ampyra during trials were 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 skin. It can also cause seizures if the recommended dosage of 10mg twice daily is exceeded.
Ampyra is not recommended for use in patients with moderate to severe kidney disease as blood levels with the drug approach those associated with the occurrence of seizures.
Copyright Press Association 2010
US Food and Drug Administration