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Inception

On May 22, 2003, the Substance Abuse and Mental Health Services Administration announced an interim final rule that will permit opioid treatment programs serving persons addicted to heroin or narcotic pain relievers to offer buprenorphine treatment along with methadone and ORLAAM.

Subutex

Subutex is formulated as a sublingual tablet that contains either 2 or 8 milligrams of buprenorphine. Suboxone is a fixed combination sublingual tablet that contains 2 milligrams of buprenorphine with 0.5 milligrams of naloxone, and 8 milligrams of buprenorphine together with 2 milligrams of naloxone. Naloxone is an opioid antagonist and is present in the Suboxone formulation to reduce its risk of intravenous abuse.

A Step Forward

Subutex and Suboxone now join methadone as medications that will be available for the treatment of heroin and other opiate addiction. They offer a broader array of options to physicians and patients and should expand treatment availability. These products represent the culmination of several years of research and development between NIDA and Reckitt Benckiser Pharmaceuticals, Incorporated..

Suboxone versus Methadone

junkie Currently opiate dependence treatments like methadone can be dispensed only in a limited number of clinics that specialize in addiction treatment. There are not enough addiction treatment centers to help all patients seeking treatment. Subutex and Suboxone are the first narcotic drugs available under the Drug Abuse Treatment Act (DATA) of 2000 for the treatment of opiate dependence that can be prescribed in a doctor’s office. This change will provide more patients the opportunity to access treatment.


A New Solution

Over the past decade, heroin has become more available, purity levels have increased, and street prices for the drug have dropped. As a result, there has been a dramatic increase in heroin addiction in Maine and the nation. Diversion and abuse of OxyContin and other prescription narcotics has also increased at an alarming rate in the past few years, prompting intensive federal, state, and community responses to the problem of opioid abuse.

The crisis of opioid addiction in America has been fueled by the diversion of prescription pain pills and the emergence of pure and inexpensive heroin. Until recently, benefits of and access to therapy were limited. This situation changed in 2003 with Food and Drug Administration approval of buprenorphine for the office-based treatment of opioid dependence. Now armed with a potent drug, primary care physicians can treat addicted patients in their own practice and from their own neighborhood, but first we must overcome deficiencies in our training and personal biases about addicts and what they need.

Suboxone, manufactured by Reckitt Benckiser Pharmaceuticals, is the proprietary name for a pill that combines buprenorphine and naloxone. Buprenorphine is a partial opioid agonist that—like heroin, methadone, and oxycodone—stimulates the brain’s mu (morphine) receptor. Because it has a stronger affinity for the receptor site than full agonists, it displaces opioids already attached. And it is slower to dissociate, remaining active for up to 48 hours. Buprenorphine’s agonist effect plateaus at a moderately low dose, above which no additional pleasure or respiratory depression is observed. Naloxone, an opioid antagonist, was combined with buprenorphine to minimize abuse. Ingested sublingually, naloxone has little activity, but intravenous administration antagonizes the action of buprenorphine. This mechanism diminishes its street value as an intoxicant, but it has been used as a bridge to the next heroin fix. All of these qualities make Suboxone an ideal agent for the treatment of opioid addiction. What patients and clinicians quickly grasp is that it works: it prevents withdrawal symptoms, eliminates cravings, and restores regularity to a disjointed life.


Clinical View

physician "The availability and application of buprenorphine marked a new day in the treatment of addiction," said SAMHSA Administrator Charles G. Curie, M.A., A.C.S.W. "With this interim final rule, physicians for opioid treatment programs will be able to improve, expand, and tailor treatment for the individual needs of their patients."