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FDA Grants Fast Track Designation For MediciNova's MN-166 (ibudilast) For The Treatment Of Methamphetamine Dependence

About Methamphetamine Addiction

Methamphetamine is a very addictive stimulant that is closely related to amphetamine. It is long lasting and toxic to dopamine nerve terminals in the central nervous system. It is a white, odorless, bitter-tasting powder taken orally or by snorting or injecting, or a rock "crystal" that is heated and smoked.

Methamphetamine increases wakefulness and physical activity, produces rapid heart rate, irregular heartbeat, and increased blood pressure and body temperature. Long-term use can lead to memory loss, aggression, psychotic behavior, heart damage, malnutrition and severe dental problems. All users, but particularly those who inject the drug, risk infectious diseases such as HIV/AIDS and hepatitis.

About MN-166 (ibudilast)

MN-166 has been marketed in Japan and Korea since 1989 to treat cerebrovascular disorders, including post-stroke complications, and bronchial asthma. MediciNova licensed MN-166 (ibudilast), from Kyorin Pharmaceutical in October 2004 for potential utility in relapsing remitting multiple sclerosis. MediciNova scientists and collaborators independently established evidence of ibudilast utility in opioid and methamphetamine addiction as well as chronic neuropathic pain.

MN-166 is a first-in-class, orally bioavailable, small molecule phosphodiesterase (PDE) -4 and -10 inhibitor and a macrophage migration inhibitory factor (MIF) inhibitor that suppresses pro-inflammatory cytokines including IL-1ß, TNF-a, and IL-6, and may upregulate the anti-inflammatory cytokine IL-10 and neurotrophic factors. It has additionally been shown to be a toll-like receptor 4 (TLR4) functional antagonist that may contribute to its therapeutic action.

MediciNova's development efforts in progressive MS and chronic neuropathic pain is also founded upon both preclinical and clinical data indicating anti-neuroinflammatory and neuroprotective actions, which may be beneficial in those conditions.

MediciNova's method-of-use patent for MN-166 for the treatment of addiction expires no earlier than 2030 in the U.S. In the approved and pending grant-funded MN-166 trials, one of MediciNova's commitments is to provide delayed-release ibudilast final product. A drug supply collaboration with Taisho Pharmaceutical Industries, Ltd., owned by Teva Pharmaceuticals, has expanded to include development of higher dosage strength ibudilast capsules.

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