FDA considers new, implantable treatment for heroin, painkiller addiction ... Fighting drugs with drugs

Sunday, January 31, 2016 by: Jennifer Lea Reynolds
Tags: opioid addiction, Probuphine, buprenorphine

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(NaturalNews) It's no secret that opioid addiction is a serious problem; the statistics speak for themselves. According to the Centers for Disease Control and Prevention (CDC), nearly 7,000 people are treated in emergency departments on a daily basis, because they used prescription drugs in ways that are inconsistent with their intended use. In 2013 alone, about two million Americans abused painkillers, most commonly Hydrocodone, Oxycodone, Oxymorphone, and Methadone – typically known as Vicodin, OxyContin and Opana, respectively. However, the list is virtually endless, and is not just limited to these drugs in particular.⁽¹⁾

On an almost routine basis, stories arise involving deaths or serious health issues that stem from opioid addiction, emphasizing the fact that the issue is spiraling out of control.

These stories even involve innocent babies who are born addicted; it's estimated that in the past decade alone, approximately 130,000 U.S. babies have been born with drug addictions. Some of their mothers admit to getting high, and consequently, killing their children. Others recall shooting up drugs at the very same time they were in labor, right on the floor at home. The problem is shocking and it's very, very, real.⁽²⁾

Pharma company says it has solution to help opioid-addicted people

To address this growing issue, New Jersey's Braeburn Pharmaceuticals has manufactured an implant designed to ease withdrawal symptoms, reduce cravings and minimize the chances of a relapse. Called Probuphine, the implant is said to provide a steady dose of buprenorphine, a medication that the pharmaceutical company says plays a role in meeting those goals.⁽³⁾

In fact, it's been shown to be beneficial, at least according to a 2010 article published in The Journal of the American Medical Association (JAMA). Entitled, "Buprenorphine Implants for Treatment of Opioid Dependence: A Randomized Controlled Trial," the study detailed a randomized, placebo-controlled, six-month trial in which 163 opioid-dependent adults were treated – some with the buprenorphine implant, and others with a placebo implant. The detailed study ultimately concludes that, "Among persons with opioid dependence, the use of buprenorphine implants compared with placebo resulted in less opioid use over 16 weeks as assessed by urine samples."⁽⁴⁾

That study also noted:

"This study demonstrated that buprenorphine implants are effective in the treatment of opioid dependence over a 24-week period following implantation. Of particular clinical importance are the favorable urinalysis toxicology results and the good patient retention—with 65.7% of patients who received the active implants completing 24 weeks of treatment without experiencing craving or withdrawal symptoms that necessitated withdrawal from the study."⁽⁴⁾

But will it be approved? Relapse, infection cited as concerns

Now, it's up to the FDA to weigh in and decide whether or not they'll approve the implant.

However, at a recent committee meeting to discuss the issue of opioid addiction and the buprenorphine implant, some people expressed hesitation over possible approval, strongly urging the FDA to make a move against it.

For example, the implant would have to be removed and replaced every six months, increasing the risk of infectious complications that arise with such routine incisions.⁽³⁾

There's also the concern of an addicted person having a relapse. Since it takes upwards of four weeks for the implant to deliver the same medication level that buprenorphine film strips do, patients will still have to keep taking buprenorphine orally for the first few weeks after they get the implant. As such, Tracy Rupp, director of public health policy initiatives at the National Center for Health Research, says a relapse during such a transition is entirely possible, and poses "... an unacceptable risk for stable patients."⁽³⁾

Briefing document highlights some implant benefits

At the same time, some of the implant's benefits have been emphasized, most recently at a January 2016 committee meeting regarding the treatment of opioid dependence. A briefing from that Advisory Committee Meeting of the Psychopharmacologic Division of the U.S. Food and Drug Administration states the following:

"Probuphine has been studied in 7 clinical studies, including 3 randomized controlled studies. It has been demonstrated to be effective for maintaining patients stabilized on buprenorphine. It is expected to offer greater convenience, adherence, and ultimately satisfaction with treatment. It also has the potential to dramatically reduce the risks of abuse, misuse, diversion, and accidental pediatric exposure associated with daily-dosed buprenorphine.^"(5)

As with any proposed solution to a health problem, there are pros and cons, with much to be explored. In the case of the opioid crisis, is such an implant the answer? Or is it akin to fighting drugs with drugs?

Sources for this article include:

(1) CDC.gov

(2) NaturalNews.com

(3) KCENTV.com

(4) Jama.JamaNetwork.com

(5) FDA.gov^[PDF]