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MN-166 (Ibudilast) Granted “Fast Track” Designation by FDA to Speed its Potential Approval for Progressive MS

March 22, 2016

MediciNova, Inc. has announced that the experimental oral therapy MN-166 (ibudilast) has been designated by the U.S. Food and Drug Administration as a “Fast Track Product” in terms of its development as a possible treatment of progressive MS, including secondary progressive and primary progressive MS. Fast Track is a process designed to facilitate the development, and expedite the review of, treatments for serious conditions and fill an unmet medical need (read more on the FDA Web site). Fast Track would apply once the company submits the data from phase III trials to the FDA, along with a New Drug Application.
Investigators are currently conducting a phase II clinical trial of ibudilast in 250 people with progressive forms of MS, at 28 sites nationwide. The study, called the SPRINT-MS trial, is principally funded by the National Institutes of Neurological Diseases and Stroke (NINDS), with additional support by MediciNova and the National MS Society. This trial is ongoing with all participants enrolled, and is expected to report results in 2017.
“This is good news for people with progressive forms of MS, for which there are few treatment options,” says Bruce Bebo, PhD, Executive Vice President, Research at the National MS Society. “We look forward to the completion of this groundbreaking clinical trial and the FDA’s Fast Track review of the results.”
Among other actions, ibudilast inhibits an enzyme called phosphodiesterase, and has been shown to protect brain tissue in animal models. While considered a “New Chemical Entity” in the United States and Europe, ibudilast is marketed in Japan and Korea to treat asthma and symptoms from cerebrovascular disorders. In a previous study, ibudilast did not reduce relapses or MRI-observed new lesions in a phase II trial involving people with relapsing MS. However, some evidence that this agent could protect the nervous system from damage (neuroprotection) was observed, which is why it’s being tested further in people with progressive forms of MS. (Neurology 2010;74:1033)
Read about more agents under study for progressive MS (pdf).

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system. Symptoms range from numbness and tingling to blindness and paralysis, and there is currently no cure for MS. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. An estimated 1 million people live with MS in the United States. Most people with MS are diagnosed between the ages of 20 and 50, and it affects women three times more than men.


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