January 24, 2009

Merck Pill Prevents MS Relapse

Merck Serono announced on Friday that it was drawing closer to releasing the first pill to treat Multiple Sclerosis (MS), the most common neurological condition affecting young adults.

In a press statement, the German drugmaker said that patients taking its cladribine tablets experienced a nearly 60 percent lower relapse rate than those taking placebo pills.

The two-year study, funded by Merck, included 1,326 patients with MS who were divided randomly into three groups. Two groups received different doses of cladribine, while the other group received a placebo pill.

Compared to patients taking the placebo, those taking the cladribine pills had up to a 60 percent reduced chance of having a relapse.

"This is promising news," said Dr. Lee Dunster, head of research for Britain's Multiple Sclerosis Society and not involved in the study, told the Associated Press.

He added cladribine appeared to be twice as effective as current primary MS treatments.

MS is the result of damage to myelin, the protective coating on nerve fibers.  When this happens, it interrupts the brain's messaging to other parts of the body.  Patients suffering with MS often experience fatigue, muscle spasms, problems with speech, vision, coordination, and the bladder.  There is no known cure, and relapses are often unpredictable.  Existing MS must be given by injection, and success rates vary widely.

Cladribine is currently used to treat leukemia, but only for short duration. Physicians say more information is needed about the drug's potential side effects with long-term use, since MS is a lifelong condition. Known cladribine side effects include anemia, fatigue and an increased chance of infections.

Merck has already asked regulators in Europe and the U.S. fast-track the drug to the market.  And the company said in its press statement that they will submit cladribine for registration in both regions later this year.

Merck's competitor, Swiss pharmaceutical Novartis AG, is also working on a pill to treat MS.

Although Merck's study found that cladribine reduced rate of relapse, Dunster is curious whether the drug can slow progression of the disease as well, and expects that data to be released in the coming months.

"Relapses are not very nice things to have, but we are really looking to slow down the disease," he said.

"For patients, it's all about whether or not they will be able to kick around the ball with their kids in a few years."


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