We all know the federal government moves slowly, so with this good news we are urging only cautious optimism. However, substance abuse treatment professionals across the nation are perking up joyous ears, eager to learn more about a recommendation by an FDA Advisory Panel to approve the use of Probuphine, a buprenorphine implant, to treat opiate addiction.
Liz Szabo of USA Today was the first to report to the public in January 2016 what the Food and Drug Administration’s Advisory Panel recommended less than a month before. Patients would have the buprenorphine implant, no bigger than a match stick, inserted beneath the skin. It’s a simple procedure that can be done in a doctor’s office. For a period of six months it would release a steady supply of buprenorphine, recognized as one of the two most effective drugs that we have in our arsenal to battle opiate addiction.
Both buprenorphine and methadone have long been approved as effective methods for treatment of addiction to pain pills, heroin, and other opiates. While methadone requires a person’s attendance on a daily basis at a clinic that administers the medication, buprenorphine can be prescribed by a doctor in his office as long as he has undergone the training mandated by the government.
The buprenorphine implant has been on the horizon for several years now, but talk went silent over the past 18 months. This recent news means that people who opt for the implants will receive convenient treatment with out weekly or monthly doctor visits to obtain their medication. The government would still recommend participation in outpatient counseling in order to supplement the medication and help the person work through issues that led to their addiction in the first place.
Buprenorphine Implant: Addressing a Substantive Risk
One of the biggest risks of buprenorphine treatment is possible diversion of the medication. Buprenorphine implants would eliminate that risk.
Most people realize that you cannot get high from buprenorphine because it is a partial opiate agonist, unlike methadone, which is a long-acting full opiate agonist. With a full opiate agonist, the person can take the medication to get high, and in truth there are people out there who choose to abuse methadone.
However, with buprenorphine in its brand-name form of Suboxone, its partial agonist qualities mean that its molecules insert themselves in the brain’s opiate receptors and it blocks the brain from locking onto molecules from other opiates. The naloxone in the Suboxone prevents the brain from responding to other opiates. There is a ceiling to the euphoric effects that can be felt by taking buprenorphine. As a result, people who participate in buprenorphine treatment programs take their medication daily, but they do not experience any euphoria from it. Once they have taken their daily dose they can go about their day with no withdrawal symptoms or the cravings that drive people back relapse.
Unfortunately, buprenorphine costs more than methadone. For that reason, many people divert it in order to cover the costs of treatment. Once they have their prescription filled, they take half the dose prescribed by the doctor and they sell the rest of it. Or, in a household in which two people are abusing opiates, one of them goes into treatment and that person gives half of their buprenorphine to their partner. That’s one of the reasons why buprenorphine is most often dispensed as a film—the film, which dissolves under the tongue, makes it more difficult to handle and give out to others.
Many people who take buprenorphine do not realize that there are little code numbers on the filmstrips, and if they are called in for a “strip count”—they have to show their empty film strips to the nurse at the clinic or office where their doctor practices—the codes can be used to show if the person has substituted street-obtained buprenorphine in place of a quantity that they’ve diverted. It is also available in a pill form. Pregnant women often take buprenorphine without the naloxone in order to protect their unborn babies.
Szabo cites statistics from the Substance Abuse and Mental Health Services Administration (SAMHSA) that use of buprenorphine reduces fatal opiate drug overdoses by half. That’s a pretty significant statistic when you hear, from the Centers for Disease Control and Prevention, that fatal drug overdoses doubled in the last fifteen years, with more than 44,000 Americans dying in 2014.
Despite the frightening statistics, thousands of Americans are still alive, battling their addiction, hoping to find some kind of happiness in their lives. Those are the people who will benefit from the buprenorphine implant that may actually make it to the market place before long. There’s no indication how long it will take before the FDA approves Probuphine buprenorphine implants, but it generally does accept and act on the advice of its advisory panels.
Criticisms of the Buprenorphine Implant Trial
The Advisory Panel voted 12 to 5 in favor of the Probuphine buprenorphine implant. What about the five who voted against it? One panelist stated that treatment for opiate abuse can take much longer than six months. Yet the Titan Pharmaceutical website describes that re-treatment was available for the people in the trial who wanted to continue with the medication.
Another panelist felt the study had too many flaws. The subjects who took the medication in the double-blind study—meaning that nobody knew for certain if they received the buprenorphine implants or a placebo—were required to render urine drug screens every other day. If a person missed the screen, it was counted as a positive drug screen. Also, buprenorphine was given orally to people while they adjusted to the buprenorphine implant, as would be the case in a real-life transition from buprenorphine to a buprenorphine implant, and excessive oral doses were counted against the study.
A third panelist complained that 84 percent of the test subjects were white, and that person felt that the study did not demonstrate real-life demographics. That may be true, but it’s undeniable that the people who participated in the study and felt that they had received the medication rather than the placebo did, in fact, feel better without abusing opiates. Rendered drug screens backed up that subjective assessment showing that people who received the medication had a significant reduction in the abuse of opiates.
Until the buprenorphine implant makes its way through the federal red tape still ahead, call your local medication-assisted treatment center to learn more about buprenorphine therapy. It’s never too soon to take action that could save your life.