Heroin addiction afflicts an estimated 810,000 people in this country, the great majority of who do not either seek or receive treatment. Further, in 2008 1.85 million people in the U.S. met the diagnostic criteria for abuse or dependence on opioid pain relievers, such as Oxycontin and Vicodin (NSDUH, 2009). In fact, opioid abuse (including heroin) is a worldwide problem, with between 12.8 and 21.9 million people abusing opiates in the past year (UNODC, 2010). Two recent developments in the treatment of opioid addiction herald important advances for addressing this worldwide epidemic.
First, the U.S. Food and Drug Administration (FDA) today announced its approval of Vivitrol® for the treatment of opioid addiction. Vivitrol is an extended release formulation of naltrexone, an opioid receptor antagonist. Double-blind, placebo controlled clinical trials have shown Vivitrol to be effective in preventing not only relapse to drug use following detoxification, but also to diminish cravings that often drive it. Vivitrol, initially approved by the FDA in 2006 for treating alcohol dependence, received approval for this new indication based on findings from research conducted in heroin-addicted patients in Russia. Vivitrol is the first non-narcotic, non-addictive, extended release medication approved for the treatment of opioid dependence—marking an important turning point in our approach to treatment.
Traditional treatments have included methadone (an opioid agonist), available only through specialized clinics; and more recently, bupenorphrine (an opioid partial agonist), which can be prescribed in the privacy of a doctor's office. These drugs are effective, especially when combined with counseling, but require daily dosing. As a depot formulation, dosed monthly, Vivitrol obviates the daily need for patients to motivate themselves to stick to a treatment regimen—a formidable task, especially in the face of multiple triggers of craving and relapse. This new option increases the pharmaceutical choices for treating opioid addiction, and may be seen as advantageous by those unwilling to consider agonist or partial agonist approaches to treatment. NIDA is continuing to support research on Vivitrol's effectiveness in this country, including a focus on criminal justice involved populations transitioning back into the community. This is an especially vulnerable period, associated with a high risk of relapse, overdose, and re-arrest.
Second, a new study reported in the Journal of the American Medical Association shows promising findings for an implantable formulation of buprenorphine (Probuphine), which delivers a constant dose of the medication for up to six months. Again, the goal is to improve upon the efficacy of daily administered buprenorphine, which can be undermined by poor treatment adherence, resulting in craving and withdrawal symptoms that increase the likelihood of relapse. NIDA is supporting further research on the clinical efficacy of Probuphine, in the hopes that it too will become part of the arsenal of weapons against the crippling effects of opioid addiction.
Sincerely,
Nora D. Volkow, M.D.
Director