|Suboxone: The Future of Opioid Treatment|
|Suboxone: The Future of Opioid Treatment|
...fundamentally different from methadone: A NEW OPIOID REPLACEMENT THERAPY
Dr. Ed Johnson was first introduced to buprenorphine several decades ago, when he was working at the Addiction Research Center in Lexington, KY. He chuckles at the remembrance: "Back in those days, there were only two places you could go to and get medically treated for opiate addiction treatment drug rehab alcohol rehab, with Lexington being one of them," he recalls, pointing out that it was at a time prior to the passage of the 1974 Narcotics Addiction Treatment Act, which made possible the creation of the nation's methadone clinic system. But in the ensuing decades, as the number of clinics soared and methadone emerged as the chief medical treatment for opiate addiction, Dr. Johnson and a group of colleagues stayed focused on buprenorphine, which Dr. Johnson has been known to refer to as that "beautiful molecule." Initially, back when Dr. Johnson, and colleagues of his like Dr. Donald Jasinski, began working with buprenorphine, it was being used only to treat pain under the name of Buprenex. But Dr. Johnson and Dr. Jasinski soon began to think that it might also be used to treat opiate addiction, especially after they began to have a better understanding of the drug"s unique properties. What followed was a decades long research and regulatory effort that has culiminated in the best selling drugs that today everyone knows as Suboxone and Subutex. While many think that buprenorphine is the wave of the future when it comes to treating addiction to opiates - some doctors believed in the drug so much that they began prescribing it illegally while it was still in clinical trials - Dr. Johnson is cautious when it comes to making such sweeping statements: "Yes, Suboxone is a very major advancement in the treatment of those who are addicted to opiates," he says. "But it is not a magic bullet, and there are times when other treatments, like methadone, are more appropriate." One of the major attractions of buprenorphine, indeed one of the reasons it is such a "beautiful molecule" in the eyes of researchers like Dr. Johnson, has to do with its properties as a "partial agonist" when it comes to opiates. With methadone, which is dispensed daily at about 1,000 specialty clinics across the country, opiate addicts get the full euphoric effect of an opiate because it is a "full" opiate agonist. What this means is that, if a subject is getting a strong enough dose, he or she can get high off methadone. And while this is possible with buprenorphine, it is much less so, because the drug is only a "partial" agonist. Researchers like Dr. Johnson began to refer to buprenorphine"s "ceiling effect," which is illustrated in the SAMHSA chart reproduced below, when they described the drug's attractiveness for opiate maintenance therapy.
Throughout the 1980s, Dr. Johnson, Dr. Jasinski and others continued to research buprenorphine's effectiveness as an opiate addiction treatment, much of the time under the auspices of the research arm of the National Institute on Drug Abuse, NIDA. By the early 1990s, both were becoming highly convinced that they were on to something big, a notion that was amply confirmed when the FDA identified a 1992 study as a "pivotal" trial, a designation that carries enormous weight with commercial drug companies as they consider which drugs to back in their efforts to bring new drug treatments to market.
It was at this point that NIDA and Reckitt Benckiser Pharmaceuticals - the manufacturer and marketer of Suboxone in the United States, with Schering Plough being the marketer and distributor in the many other countries in which the drug is sold - came together in a agreement that would eventually bring buprenorphine to the commercial marketplace. In their efforts to take buprenorphine commercial, Reckitt Benckiser and NIDA went down an unusual path, deciding that they wanted Suboxone- which is less prone to abuse than the earlier Subutex because the naloxone it contains immediately induces withdrawal from full agonists - to be offered as a treatment for opiate dependence in doctors offices. With the passage of legislation in 2000, finally after five attempts and herculean efforts in the face of opposition from various quarters, the stage was set for buprenorphine to become available as a medical treatment in doctors offices. The final leg came into place with approval by the FDA in 2002 of Suboxone as a treatment for opiate addiction, with the key proviso that it was to be allowed to be administered by ordinary doctors in their offices in the ordinary course of conducting their medical practice.
"This was truly revolutionary, says Reckitt Benckiser Pharmaceuticals President Shaun Thaxter, who says that his company sees much promise in addiction pharmacotherapies, adding that Reckitt Benckiser is specializing in addiction while exploring avenues to bring new treatments to market. "We view the fact that Suboxone is in the U.S., prescribed by doctors as huge." he says, especially with the medical profession to a large extent having been traditionally pushed out of the way by the powerful enforcement actions of the ever growing War on Drugs establishment, agencies like the DEA, etc... But Thaxter points out that there are now over 9,000 doctors in the U.S. that are certified to administer Suboxone from their offices. Since there are currently only about 4,000 M.D. and psychiatric specialists in addiction medicine throughout the country, Thaxter proudly points out that Suboxone's availability through doctors has meant that there has been a significant penetration into a part of the medical community that hasn't traditionally been all that focused on addiction related issues, ie: the general medical practitioners. "We think this is a very significant development for the treatment of addiction in general," says Thaxter. "Doctors, through their exposure to Suboxone, are becoming more aware of addiction as a potential problem when they see patients walk through their doors."
On the Cover: Jacob Levinson
Founder, CEO MAP