New Drug Therapy May Improve Mobility For Multiple Sclerosis Patients

Multiple Sclerosis (MS) affects about 400,000 Americans and approximately 2.5 million people worldwide, according to the National Multiple Sclerosis Society. It is a chronic and often disabling disease that attacks the brain, spinal cord, and optic nerves that make up the central nervous system. Symptoms can range from numbness in the limbs to debilitating paralysis and loss of vision. The symptoms, as well as the progression and severity of MS, are unpredictable and may vary greatly from one person to another.

MS is an autoimmune disease in which the body’s own defense system attacks a fatty substance called myelin that surrounds and protects the nerve fibers in the central nervous system. The damaged myelin forms scar tissue, or sclerosis. Nerve fibers can be damaged as well. MS patients suffer from a progressive decline in mobility and few treatment options are available beyond physical therapy. However, a new drug developed by Acorda Therapeutics Incorporated, known as fampridine, has now been shown to improve walking ability in some multiple sclerosis patients. The report on the analysis was published in The Lancet.

Andrew Goodman of the University of Rochester Medical Center in New York, and colleagues, conducted the phase III study of 301 patients ranging in age from18 to 70. Participants were randomly selected to receive either 10 milligrams of fampridine or a placebo twice daily for a period of 14 weeks. Assessments were made of the participants’ walking speeds for a distance of 25 feet after periods of two weeks, six weeks, 10 weeks and 14 weeks.

The results of the study revealed that 35 percent of the participants who received fampridine achieved a faster walking speed in a minimum of three of the four assessments compared to only 8 percent of those taking placebo. In addition, those participants taking the fampridine showed greater improvement in leg strength, improving their ability to participate in daily activities such as standing, walking outside, and using stairs.

A total of 5 percent of the participants withdrew from the study due to adverse events including two participants suffering from the severe adverse events of focal seizure and severe anxiety in connection with use of the drug. The researchers noted that in previous studies, the risk of seizure appeared to increase in accordance with dosage of fampridine.

In conclusion, the researchers wrote, “Treatment with fampridine produces clinically meaningful improvement in walking ability in some people with multiple sclerosis, irrespective of disease course type or concomitant treatment with immunomodulators.” The team also noted that more research would be necessary to confirm the study findings.

There is no known cure for MS. According to Goodman, existing drugs target slowing the progression of the disease and helping to prevent relapses, although patients may not be able to tell whether or not they are working. He explained that with fampridine pills, the patients know if it is working.

In a statement, Dr. Ron Cohen, president and CEO of Acorda Therapeutics, said, “This trial included both physician and patient assessment scales that demonstrated both improvement in walking speed and clinical meaningfulness of that improvement.” He went on to say, “The results of this study indicate that fampridine-SR could potentially represent an important new treatment option in managing MS.”

Although fampridine has shown success in the improvement of visual function, strength, walking ability, fatigue and endurance in MS patients, concerns remain as to the safety and effectiveness of the drug. Acorda submitted a new drug application for fampridine to the U.S. Food and Drug Administration on January 30th. If approved, it would be the first MS drug to reverse a symptom of the disease.

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