The FDA has granted InterveXion Fast Track Development status for IXT-m200, based on the serious nature and high unmet medical need associated with methamphetamine use.
Methamphetamine abuse and addiction are growing problems with significant impact and cost to individuals, families, the healthcare system, communities, and law enforcement. Methamphetamine addiction is a complex medical problem with many interrelated contributing factors. The intense and powerfully rewarding effects of methamphetamine use are critical in perpetuating the cycle of addiction. Pharmacologically preventing or blocking methamphetamine-induced reinforcement would be a major medical breakthrough. Unfortunately, there are no medications for this purpose, and this unsolved problem continues to be a critical barrier to the successful treatment of methamphetamine abuse and addiction.
Methamphetamine abuse carries devastating social and medical consequences, which are vastly disproportionate to the number of users. Social consequences include a range of problems like lost work productivity, environmental hazards from illegal home synthesis, and significant danger for the children of addicts. Indeed, methamphetamine is a major reason for placement of children in foster homes because incarcerated or jobless addicted parents cannot adequately care for their children and because they often conduct very dangerous illegal synthesis of the drugs in their homes (Asanbe et al, 2008). According to law enforcement officials, 20-75% of all inmates are incarcerated because of methamphetamine or methamphetamine-related crimes (Hansell, 2006). In addition to acute and chronic illnesses in the individual user, medical consequences include increased economic burden on a system that can ill-afford further demands for limited resources. For example, burn treatment centers across the US have had to close or limit therapy due to methamphetamine producers presenting with catastrophic burns that exhaust limited medical resources (Burke et al, 2008). According to a Rand report that included a full range of methamphetamine -related medical and social expenditures, the cost to the public of methamphetamine use was more than $23 billion in 2005 (Nicosia et al, 2009). Thus, methamphetamine use consumes significant municipal, county, state, and federal financial resources; this consumption could go unrecognized in a more simplistic patient or hospital cost analysis. Reducing the number of users through effective medical treatment could redirect limited community, state and federal resources into more productive avenues.