Experimental Medications: Other Therapeutic Strategies
- Oral medication
- Ibudilast is being studied in progressive MS
Ibudilast (MN-166) is an oral agent with novel immune modulating and potential neuroprotective properties that is being studied in progressive forms of MS. This agent has also been studied in a range of conditions including chronic pain, headache, and in the treatment of methamphetamine-dependent addicts. Based on early MS-trial evidence that ibudilast had a primary, neuroprotective role, independent from a substantial effect on overt inflammation, the Phase II Secondary and Primary Progressive MS Ibudilast NeuroNEXT trial (SPRINT-MS)24 was launched in fall 2013. It includes 28 enrolling clinical sites across the United States.
The trial is designed to evaluate the safety, tolerability, and efficacy of ibudilast administered twice daily to individuals with PPMS or SPMS. Primary outcomes of this trial will be MRI findings, including brain atrophy, as this is felt to be an important aspect of progression in MS. There will also be several other imaging and clinical-disability outcomes evaluated. The NIH and National MS Society are supporting the study along with a commercial partner, MediciNova. The trial is expected to require approximately three years for enrollment, treatment, and data analyses, and will run through the end of 2016.
In March 2016, ibudilast received Fast Track designation from the FDA. This designation is intended for drugs under development for treating serious diseases and with the potential to address unmet medical needs for such diseases. According to the FDA, Fast Track designation for a drug makes it eligible for things such as more frequent communications with the FDA, priority review, and the potential for accelerated approval.