WASHINGTON -- The FDA has approved the first drug that improves walking in patients with multiple sclerosis, the tablet dalfampridine (Ampyra).
The approval was based on clinical trial data that found patients could walk better with the drug than those treated with placebo.
Patients who exceed recommended dosage, 10 mg twice a day, or who have moderate to severe kidney disease, may experience seizures the FDA said.
Adverse events reported during clinical trials include urinary tract infection, insomnia, dizziness, headache, nausea, weakness, back pain, balance disorder, swelling of the nose or throat, constipation, diarrhea, indigestion, throat pain, and burning, tingling, or itching skin.
The drug is manufactured by Elan of Dublin, Ireland and distributed by Acorda Therapeutics Inc. of Hawthone, NY.