New Oral Drugs Hailed for Treating Multiple Sclerosis

MONDAY Jan. 31, 2011 -- For decades, research into treatments for multiple sclerosis has plodded forward, making slow but significant gains in improving the lives of people with the degenerative nerve disorder.

That steady but slow pace made the speed at which progress occurred in the past year nearly breathtaking, with the U.S. Food and Drug Administration approving a number of new breakthrough drugs for people with MS.

Nicholas LaRocca, vice president of health-care delivery and policy research for the National Multiple Sclerosis Society, said that 2010 was "an unprecedented year for MS, both in terms of the many developments that are in the pipeline as well as drugs that have come to market."

The new medications broke new ground not only through the therapy they provide but also in the way they are administered. The drugs can be taken orally, a break from past MS treatments that had to be given by either injection or IV.

They include:

  • Gilenya (fingolimod), the first oral medication designed to reduce relapses and delay the progression of MS.
  • Ampyra (dalfampridine), the first drug approved to treat a specific symptom of MS - in this case, improving people's ability to walk.
  • Nuedexta, a two-drug combination designed to treat people with MS who have lost emotional control because of a symptom known as pseudobulbar affect, a severe emotional consequence of the disorder that causes uncontrollable laughing or crying.

Other oral therapies are in the pipeline. One now under FDA review is cladribine, a drug aimed at reducing relapses that could further improve convenience for people with MS, LaRocca said.

"It is taken orally but in discrete blocks of time over the course of the year," he said. "It's a couple of very short courses of oral therapy, as opposed to taking it constantly."

LaRocca said that these and other new drugs that have hit the market or on the verge of FDA approval will make it much easier for those with MS to find relief.

"People respond differently to different therapies," he said. "The more treatments we have, the higher the likelihood that a person will find a treatment that works best for them. We're going to see a steady stream of options for people with MS, providing people with the choices they need."

The new oral therapies also help people regain some small sense of control by allowing them to more easily take their medications, said Dr. Ron Cohen, chief executive and founder of Acorda Therapeutics, the company that developed Ampyra.

"It's certainly a more convenient form of the type of therapy that's already been available as an injection," Cohen said. "What's not known right now is, of all the orals, the relative efficacy of these orals versus the best of the injectables. With the injectables, there's a pretty good sense of what to expect in terms of efficacy and safety. It will take several years to develop such a track record for oral medications."

With the approval of the new drugs, eyes are turning toward the future and the next potential advance in MS treatment. Both Cohen and LaRocca said that treatments that repair the neural damage caused by multiple sclerosis are the next frontier for researchers.

Multiple sclerosis is now believed to be an autoimmune disorder in which the body damages the nervous system by attacking myelin, the fatty substance that surrounds and protects nerve fibers, according to the National Multiple Sclerosis Society.

The drug Ampyra works by restoring the conductive power of nerves that have lost their myelin, Cohen said.

"Right now, there's nothing that can repair the damage once it's been done," he said. "If we had something that could restore the myelin, you could potentially dial back the damage done by the disease."

The National Multiple Sclerosis Society supports four research centers, two in the United States and two in the United Kingdom, that are focused on neural protection and repair, LaRocca said.

"We have drugs that can slow or stop the progression of MS," he said. "We don't have treatments that can repair the damage to the nervous system caused by MS. That's really the next frontier. That's what we hope to see in the pipeline in the future."

More information

The U.S. National Institute of Neurological Disorders and Stroke has more on multiple sclerosis.

Posted: January 2011


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