MediciNova Inc. announced that it has received Fast Track designation from the U.S. Food and Drug Administration 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.
According to the Substance Abuse and Mental Health Services Administration's (SAMHSA) 2011 National Survey on Drug Use and Health, there are approximately 439,000 methamphetamine abusers in the U.S. An independent study conducted by the Rand Corporation estimated the economic burden of methamphetamine use in the U.S. at $23.4 billion in 2005.
There are no medications currently approved by the FDA for the treatment of methamphetamine dependence. Herbert D. Kleber, founder and Director of the Division on Substance Abuse, New York State Psychiatric Institute, and Professor of Psychiatry at Columbia University Medical Center, and a prior Deputy Director at the White House Office of National Drug Control Policy noted that "there truly is an unmet need for pharmacotherapy treatment of methamphetamine dependence and the recognition of such need by the FDA is positive for the field."
"We are very pleased that MN-166 has received Fast Track designation and believe this validates its potential to address unmet medical needs in this devastating and life-threatening disease," Dr. Yuichi Iwaki, President and CEO of MediciNova commented. "We look forward to initiating the NIDA-funded Phase 2 outpatient clinical trial of MN-166 for the treatment of methamphetamine addiction with UCLA investigators."
Date: February 26, 2013
Source: MediciNova Inc.