Experimental Pill May Treat MS
Study: Oral Fumarate Reduces New Brain Lesions in Patients With Relapsing-Remitting Multiple Sclerosis
Oct. 23, 2008 -- An experimental pill may help curb brain lesions in patients with relapsing-remitting multiple sclerosis (MS), which is the most common form of MS.
That finding comes from a new study, published in the Oct. 25 edition of The Lancet.
The pill, which contains a chemical called fumarate, isn't on the market yet; its safety and effectiveness are still being tested. But so far, those tests have yielded good results, according to the researchers, who included professor Ludwig Kappos, MD, of Switzerland's University Hospital Basel.
Kappos and colleagues studied 257 adults with relapsing-remitting MS in Europe, Russia, and Turkey for 48 weeks. During that time, the patients took either a higher or lower dose of fumarate or a placebo pill without knowing which pill they were taking. Half way through the trial, some of their pill assignments were changed.
Patients got magnetic resonance imaging (MRI) brain scans when the study started and periodically throughout the study.
Those brain scans showed positive results in patients taking the higher fumarate dose three times daily. For instance, those patients had a 69% reduction in the average number of a certain type of brain lesion, compared to patients taking the placebo, from week 12 to week 24 of the study.
The fumarate pill was "safe and generally well tolerated," write the researchers. But there were side effects, including flushing and abdominal pain, especially in the early phases of fumarate treatment.
During the first half of the study, 16 of the 64 patients assigned to take the higher dose fumarate pill three times daily stopped doing so. That's "worrying," states an editorial published with the study.
But the editorialists don't write off the fumarate pill. They point out that MS pills would be convenient and would probably be preferred by most patients, as long as pills are as safe and effective as injectable MS drugs.
There are other MS pills in the works, and the results of ongoing studies may help show how fumarate and other pills fit into the treatment of relapsing-remitting MS, note the editorialists, who included Per Soelberg Sorensen, MD, DMSc, of the Danish Multiple Sclerosis Research Center in Copenhagen, Denmark.
The study was funded by Biogen Idec, which made the fumarate pill. In The Lancet, several of the researchers and editorialists report financial ties to various drug companies, including Biogen Idec.