FDA grants fast-track designation for MediciNova's compound to treat meth dependence
Step is important, as there are no medications currently approved by the FDA for the treatment of methamphetamine dependence
SAN DIEGO—MediciNova Inc., abiopharmaceutical company that is publicly traded on the NASDAQ GlobalMarket and the Jasdaq Market of the Osaka SecuritiesExchange, announced Feb. 25 that it has received FastTrack designation from the U.S. Food and Drug Administration (FDA) forMN-166 (ibudilast) for the treatment of methamphetamine dependence.
FastTrack is a process designed to facilitate the development and expeditethe review of drugs that are intended to treat serious diseases and havethe potential to fill an unmet medical need, in this case the approximately 439,000 methamphetamine abusers in the United States, carrying with them an estimated economic burden of $23.4 billion in2005 alone, according to a Rand study.
No medications are currently approved by the FDA for the treatment ofmethamphetamine dependence.
"We are very pleased that MN-166 has received Fast Track designationand believe this validates its potential to address unmet medical needsin this devastating and life-threatening disease," Dr. Yuichi Iwaki, president and CEO of MediciNova, commented. "We look forward toinitiating the NIDA-funded Phase II outpatient clinical trial of MN-166for the treatment of methamphetamine addiction with UCLA investigators."
MN-166 has been marketed in Japan and Korea since 1989 to treatcerebrovascular disorders such as post-stroke complications, as well asbronchial asthma. MediciNova licensed MN-166 from KyorinPharmaceutical in October 2004 for potential utility in relapsingremitting multiple sclerosis. MediciNova scientists and collaboratorsindependently established evidence of ibudilast utility in opioid andmethamphetamine addiction as well as chronic neuropathic pain.
MN-166 is a first-in-class, orally bioavailable, small moleculephosphodiesterase (PDE) -4 and -10 inhibitor and a macrophage migrationinhibitory factor (MIF) inhibitor that suppresses pro-inflammatorycytokines including IL-1ß, TNF-a, and IL-6, and may upregulate theanti-inflammatory cytokine IL-10 and neurotrophic factors. It hasadditionally been shown to be a toll-like receptor 4 (TLR4) functionalantagonist that may contribute to its therapeutic action.
SOURCE: MediciNova news release
