New MS Pill on the Horizon

There are more than 400,000 people with multiple sclerosis in the United States, but there's no pill treatment for this debilitating disease.

That could change soon, though, because a promising oral medication is in the drug development pipeline, according to a study in today's New England Journal of Medicine.

Although there are injectable treatments for those with MS, most of them increase the risk of skin reactions and infections, so a pill-based form of medication is eagerly awaited.

An international group of researchers gave different doses of the experimental drug Fingolimod to 255 patients suffering from relapsing MS, a specific form of the disease that most MS patients start out with.

MS is considered an autoimmune disease in which the body's immune system attacks itself -- attacking some protective tissues in the brain -- and creates scar tissue.

There are four types of MS: relapsing-remitting, primary-progressive, secondary-progressive and progressive-relapsing.

The investigators tracked the patients' progress over the course of the study with MRI scans and doctor evaluations.

Six months after the study began, the number of brain lesions -- areas of the brain damaged by the disease -- reduced significantly in most patients, and the majority of the patients experienced a 50 percent drop in relapses.

So does Fingolimod work better than injections? Not necessarily.

Most current injectable drugs also reduce brain lesions and can reduce MS attacks by 28 percent to 66 percent, according to clinical trials.

But MS is an unpredictable disease that can change month by month or day by day, and an MS drug that works for a patient one day may not keep working for the same patient after a while.

So, researchers were pleased to find that some patients who continued to take Fingolimod continued to respond well to it, even one year after the study began.

Unlike some injectable medications, the apparent side effects from Fingolimod, which include headaches, nausea and diarrhea, were not serious. This is important because other MS drugs, primarily Tysabri, have been linked to serious side effects, such as progressive multifocal leukoencephalopathy, the rare but serious brain infection .

There is some concern that future research may uncover a similar risk from Fingolimod, based on what scientists already know about how the drug works in the brain. But researchers want to do more studies before they decide how safe and effective this drug is.

Also, while the drug appears promising, it's not known how long it will take to get it on the market.