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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.
News For MNOV From The Last 14 Days
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August 25, 2014
19:03 EDTMNOVMedicNova to initiate clinical trial of MN-166 in ALS
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August 18, 2014
19:04 EDTMNOVMedicNova announces positive interim results of MN-166 phase 2a study
MediciNova announced positive interim results of a phase 2a clinical trial of MN-166 in opioid dependence. The study is being conducted at Columbia University and the New York State Psychiatric Institute and led by Dr. Sandra Comer, Professor of Neurobiology. The interim analysis was performed after the first seven patients had completed the study, which required a 6-week stay on the inpatient unit. MN-166 demonstrated a number of beneficial effects on the subjective, analgesic, and reinforcing effects of oxycodone. MN-166 significantly decreased the craving for heroin, cocaine, and tobacco. MN-166 also decreased the positive subjective effects of oxycodone measured by mean responses to statements such as "I Feel High" and "I Liked the Dose." MN-166 also enhanced the analgesic effects of oxycodone. MN-166 reduced the sum score on the McGill Pain Questionnaire, reduced the mean rating on the Painful scale, and reduced the mean rating on the Bothersome scale. Finally, MN-166 decreased the reinforcing effects of oxycodone.

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