Oral Drug Reduces Disease Activity In Multiple Sclerosis, Study Suggests

"All of the current treatments for MS must be injected, so having a pill you can swallow with a glass of water would be a welcome improvement for many people," said study author Giancarlo Comi, MD, of Vita-Salute San Raffaele University in Milan, Italy.

The results reported are from an extension of a six-month study with 281 people with relapsing MS, two-thirds of whom took the drug FTY720 (fingolimod) and one-third of whom took a placebo. After six months, those taking FTY720 had more than 50 percent fewer relapses, or attacks, than those who took the placebo. At that point, all of the participants could enter an ongoing extension of the study where all would receive the drug.

A total of 173 people have finished three-years of the study. Continuous use of the drug led to sustained low relapses, with more than 67 percent of the participants remaining free of relapses after three years. In addition, the inflammatory activity associated with MS, as assessed by MRI scans, remained low, with 89 percent of patients free of disease activity and 75 percent of patients free of new or newly enlarged lesions.

"The first line treatments for MS, beta interferon and glatiramer acetate, reduce the relapse rate by only about 30 percent, so this is a significant development for people with MS," Comi said.

The most frequently reported side effects of the drug were headache, fatigue, flu, and cold symptoms.

FTY720 is an immune-modulating drug that binds to a receptor site on immune cells, sequestering them in the lymph nodes. As a result, FTY720 reduces their ability to cause damage associated with the symptoms experienced by people with MS.

This research was presented at the American Academy of Neurology 60th Anniversary Annual Meeting in Chicago, April 12--19, 2008.

The study was supported by Novartis Pharma AG, maker of FTY720.