The Food and Drug Administration (FDA) has granted “fast track” designation for ibudilast, a medication that could help prevent damage to the brain in people with progressive multiple sclerosis. Ibudilast (MN-166) blocks an enzyme called phosphodiesterase and helps reduce inflammation in the body. Animal models (experimental allergic encephalomyelitis, or EAE) have shown that ibudilast may help protect brain cells from injury.
Signs of potential help
A Phase 2 study of ibudilast, published in 2010, found no effect on measures of inflammation in MS patients with relapses or patients with new or actively inflamed lesions on MRI images.
However, there was a hint of some benefits involving tissue damage. These included:
- A measure of brain volume, which is considered a measure of overall brain injury in MS
- The development of black holes, which are a measure of the amount of tissue damage within an MS lesion
- A possible reduction in the worsening of disability in patients with progressive MS
More results to come
Based on the results in the Phase 2 study, a Phase 3 study is now underway. The National Institute of Health is sponsoring this national study, and the MS Center at Swedish Neuroscience Institute is participating. The MS Center at Swedish has enrolled all of the patients needed for this study.
Researchers should complete their follow-up work with these patients soon. So far, the patients and researchers are “blinded,” meaning that we do not know who is on ibudilast and who is on a placebo. We will learn this when the study is completed, and then evaluate all of the data.
Focus on progressive MS
The FDA’s fast track designation for ibudilast means the federal agency believes there is a real need for medication to help people with progressive MS and it’s willing to evaluate this drug rapidly when it gets the study results.
What fast track means
The FDA usually evaluates fast track medications within six months of receiving data. Going forward, researchers will:
- Finish their Phase 3 study
- Analyze the data
- Add the results to existing data from other studies on ibudilast
- Submit all of the data to the FDA
At that point, the fast track clock will begin. It is important to realize that the fast track designation is not based on any knowledge of whether the results of the study will be positive or negative. Rather, it is based on the importance the FDA places on quickly finding a solution for progressive MS.
To learn more about current MS treatments at the Multiple Sclerosis Center at Swedish, call 206-320-2200 to learn about scheduling a consultation or visit our website.