FDA approves oral treatment for MS

October 24, 2011

Patients have had to rely on injections for help, but now, the very first oral medication for MS has patients talking.

Lisa Adams and Lizette Garcia were both diagnosed with MS in the prime of their lives. It's a disease that slowly robs patients of their ability to walk, see and even think clearly.

"I feel like it's unstoppable all of a sudden," Garcia said.

For years, the only treatments for patients with MS had to be injected. Now, the FDA has approved the first oral treatment called Gilenya.

"Patients are excited about that because it is an oral product. We have never had that before," said Dr. Jeffrey Dunn, Clinical Neuro-Immunologist, Stanford School of Medicine.

In MS, the body's immune system attacks myelin -- a substance that protects nerves. Gilenya works by holding certain immune cells in the lymph nodes so they can't reach the myelin. In clinical studies, Gilenya reduced MS relapses by 54 percent compared to a placebo, and by 52 percent compared to another common injectable drug. But some say doctors should be cautious when prescribing the oral medication.

"What we don't know is what can happen long-term, and we don't know that until we have a lot more patients on the drug," said Dr. Melissa Ortega, Clinical Instructor/MS Specialist, University of Miami.

Gilenya can also cause serious side effects like slowed heart rate, liver problems, headaches and a build-up of fluid in the eye. Still, Adams says she'd give it a try.

"I'm so excited to think about maybe not having to go back to injections," Adams said.

Garcia has been taking the oral drug. So far -- so good.

"I've had no side effects. I have more energy, and I feel so good, and I'm happy about," Garcia said.

Currently, there are four other oral medications in the final phase of clinical trial testing that could become FDA approved soon. One interesting fact about MS -- Dunn says the closer you live to the equator, the less at risk you are for the disease. Your chances greatly increase the further away you live.

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