Experimental Medications: Other Therapeutic Strategies
- Oral medication taken twice daily
- Being studied in progressive MS
Ibudilast (MN-166) is an oral medication with novel immune-modulating and potential neuroprotective properties that is being studied in progressive forms of MS. This experimental medication has also been studied in a range of conditions, including chronic pain, headache, and methamphetamine-dependent addiction.
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) was launched in fall 2013 at 28 enrolling clinical sites across the United States. More than 250 individuals with PPMS or SPMS were enrolled and randomized to ibudilast or placebo in a 1:1 ratio. The trial focused primarily on how the twice-daily administration of ibudilast affected whole-brain atrophy at 96 weeks, and on the safety and tolerability of the medication.
In October 2017, researchers announced that ibudilast reduced the rate of whole-brain atrophy by 48 percent compared to placebo and also demonstrated a favorable safety and tolerability profile. Individuals receiving ibudilast did not have an increased rate of serious adverse events compared to those receiving placebo, and there were no opportunistic infections, heart attacks, strokes, cancers, or deaths related to ibudilast use.
In February 2018, SPRINT-MS investigators reported that ibudilast also reduced confirmed disability progression by 26 percent compared to placebo. MediciNova, the company developing ibudilast, announced in February that on the basis of these results, it is examining a Phase III trial with approximately 700 participants to validate the efficacy of ibudilast in reducing confirmed disability progression.4
Ibudilast has 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 medication makes it eligible for things such as more frequent communications with the FDA, priority review, and the potential for accelerated approval.