The FDA ( Food and Drug Administration ) has approved Ampyra ( Dalfampridine ) extended release tablets to improve walking in patients with multiple sclerosis. 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.
Multiple sclerosis is a chronic, often disabling, disease that affects the central nervous system ( brain, spinal cord, and optic nerves ). There are about 400,000 people in the United States and 2.5 million people world-wide with multiple sclerosis.
The progress, severity, and specific symptoms of multiple sclerosis are unpredictable and vary from one person to another. Symptoms can be mild, such as numbness in the limbs, or severe, such as paralysis or loss of vision. About half of all people with multiple sclerosis experience cognitive impairments like difficulties in concentration, attention, memory, and judgment, although these symptoms are usually mild and are frequently overlooked. Depression also is common among multiple sclerosis patients.
Ampyra, when given at doses greater than that recommended ( 10 milligrams 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.
Source: FDA, 2010