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News Breaks
February 25, 2013
18:02 EDTMNOVFDA grants fast track designation for MedicNova's MN-166
MediciNova and the Jasdaq Market of the Osaka Securities Exchange (Code Number: 4875), announced that it has received Fast Track designation from the U.S. FDA for MN-166 (ibudilast) for the treatment of methamphetamine dependence. Fast Track is a process designed to facilitate the development and expedite the review of drugs that are intended to treat serious diseases and have the potential to fill an unmet medical need. An important feature of the FDA's Fast Track program is that it emphasizes early and frequent communication between the FDA and the sponsor throughout the entire drug development and review process to improve the efficiency of product development. Accordingly, Fast Track status can potentially lead to a shortened timeline to ultimate drug approval.
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September 7, 2014
19:53 EDTMNOVMedicNova announces new NIDA grant for MN-166 in opioid dependence
MediciNova announced that Columbia University and the New York State Psychiatric Institute was awarded new grant funding from the National Institute on Drug Abuse, NIDA, to continue clinical research on MN-166, ibudilast, in opioid dependence. The new grant will support the completion of a Phase 2a clinical trial of MN-166, ibudilast, in opioid dependence, for which positive interim results were previously reported by MediciNova on August 18. The principal investigator, Dr. Sandra Comer, PhD, Professor of Neurobiology at Columbia University and the New York State Psychiatric Institute commented, "We are honored to receive this grant from NIDA with more than $2.66 MM for the next nine months and to be notified of a potential award of more than $11 MM for the next four years." Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, "We are very pleased with NIDA's continued support of clinical research on MN-166 (ibudilast) in opioid dependence. We look forward to additional data as the study advances."

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