FDA Approves Ampyra

Feb 1 2010


The U.S. Food and Drug Administration approved Ampyra (dalfampridine) extended release tablets to improve walking in patients with multiple sclerosis.  In clinical trials, patients treated with Ampyra ( pronounced am-PEER-ah) had faster walking speeds than those treated with an inactive pill (placebo).

Ampyra is a compound that blocks potassium channels which allows nerves to transmit impulses better.  Two phase III trials of Amprya 10 mg twice a day showed benefits in some people with MS on their ability to walk 25 feet. 

In the first study, 72 patients were treated with placebo and 228 patients were treated with Ampyra over 14 weeks.  Of the 35% of patients who responded to Ampyra, the average change in walking speed increased 25%.

In the second study, 119 patients were treated with placebo and 120 patients were treated with Ampyra over 8 weeks.  43% of treated patients responded.   Ampyra worked in all MS types including relapsing remitting, secondary progressive and primary progressive disease.

The side effects of Amprya include dizziness, trouble sleeping, headache and fatigue.  Although these two trials did not report any seizures, seizures have been reported in people on higher doses of the same active chemical also called 4-aminopyridine.  One seizure can legally prevent you from driving for 6 months in some states.  4-aminopyridine capsules can be made at some compounding pharmacies, but Ampyra will soon be widely available.

Goodman AD. AAN 5/1/07; ECTRIMS 9/20/08 P909.

BY: Barry Singer, MD DATE: February 1, 2010 TOPIC: MS Research News