FDA Okays Ampyra for Multiple Sclerosis

Saturday Jan 23, 2010 (foodconsumer.org) -- The Food and Drug Administration announced on Jan 22 that it has approved Ampyra (dalfampridine) made by Acorda Therapeutics, to improve walking in patients with multiple sclerosis (MS). 

Multiple sclerosis is a chronic and usually progressive disease in which the immune system attacks and degrades nerve fibers of the central nervous system—the brain, spinal cord, and optic nerves. About 400,000 people in the United States, mostly aged 20 to 40, have the disease; world-wide, 2.5 million people are affected. 

Acorda Therapeutics said it is happy with the FDA approval and issued a statement on the same day saying "AMPYRA demonstrated efficacy in people with all four major types of MS (relapsing remitting, secondary progressive, progressive relapsing and primary progressive." 

Results from two phase 3 MS trials showed Ampyra, when administered as a 10mg tablet twice a day, improved the walking speed in patients. 

In one trial, increased walking speed was observed in 34.8 percent of those on the drug compared to 8.3 percent taking a placebo. In another trial, 42.9 percent of those treated with the new drug improved their walking speed, compared to 9.3 percent in patients who took a placebo. 

Acorda Therapeutics said that a significantly greater proportion of patients taking Ampyra have increased their walking speed by 10 to 30 percent, compared to the walking speed at the time they began the trial, pre-Ampyra. 

But the company also said the difference in walking speed between the drug and placebo was not established, meaning that exactly how much better the drug was than the placebo in helping patients to walk remains unknown. 

The common adverse events, which were found in more than 2 percent of patients, a rate that is greater than the placebo rate, include "urinary tract infection, insomnia, dizziness, headache, nausea, asthenia, back pain, balance disorder, multiple sclerosis relapse, paresthesia, nasopharyngitis, constipation, dyspepsia, and pharyngolaryngeal pain," both the FDA and the drug maker said. 

When the medication was used in overdose, risk of seizures increased. 

Ampyra is not indicated for patients with moderate to severe renal impairment nor for those who have had seizures, said the company which expect to place the drug in the market in March 2010. 

The common multiple sclerosis symptoms include numbness or weakness in one or more limbs, loss of vision, double vision or blurred vision, tingling or pain in parts of the body, tremor or lack or coordination, fatigue and dizziness. 

There is no cure for the disease and multiple sclerosis drugs include corticosteroids, interferons, glatiramer, natalizumab, and mitoxantrone. Exercise may also help.

Reporting by Jimmy Downs and editing by Rachel Stockton