Ibudilast Receives Fast Track Designation from FDA
MediciNova, Inc., the biopharmaceutical company developing ibudilast (MN-166), announced that this investigational medication for progressive forms of MS has received Fast Track designation from the United States Food and Drug Administration (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 some or all of the following: more frequent communications with the FDA; a rolling review, where the sponsor may submit completed sections of its New Drug Application (NDA) as they are ready, rather than wait for every section to be completed before submitting; a priority review, with the FDA’s goal to take action on an application within six months of submission, versus 10 months for a standard review; and the potential for accelerated approval. Once Phase III trial data are available for ibudilast, these may be submitted to the FDA (along with the NDA) and the Fast Track designation would become effective. (Please note that the Phase II trial will not be completed until the end of 2016, so Phase III data – needed to submit ibudilast for approval – will not be available until a much later time.)
Ibudilast is an oral agent with novel immune modulating and potential neuroprotective properties that is being studied in both secondary-progressive MS (SPMS) and primary-progressive MS (PPMS). This agent has been studied in a range of other conditions including chronic pain, headache, and in the treatment of methamphetamine-dependent addicts. It has also been marketed in Japan and Korea since 1989 to treat post-stroke complications and bronchial asthma.
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 the fall of 2013. It includes 28 enrolling clinical sites across the United States. The trial is expected to require approximately three years for enrollment, treatment, and data analyses, and will run through the end of 2016.
The trial is designed to evaluate the safety, tolerability, and efficacy of MN-166 (ibudilast) administered twice daily to individuals with SPMS and PPMS. 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.
Please note that some of the information provided in this news article originally appeared in MSAA’s 2015 MS Research Update.
For more information or to speak with a trained Client Services Specialist, please call MSAA’s Helpline at (800) 532-7667, extension 154. Questions to MSAA’s Client Services department may also be emailed to MSquestions@mymsaa.org.
Written by Susan Courtney, MSAA Senior Writer
Reviewed by Donald A. Barone, DO, Member of MSAA’s Healthcare Advisory Council