Malibu Beach Recovery Center

Buprenorphine has been in the news lately.  A pharmaceutical company is seeking FDA approval for implants that release the drug, and it’s not without controversy.

If you need a refresher on this drug, it’s used to treat opioid addiction (addiction to painkillers like OxyContin andVicodin, for example). When used in Subutex and Suboxone, it “enable[s] opioid-addicted individuals to discontinue the misuse of opioids without experiencing withdrawal symptoms,” according to SAMHSA. It carries a lower risk of abuse than heroin and methadone, which is designed to perform the same function, although the potential is there, experts say.

And that was one of the concerns the FDA voiced when the drug came up for review this month. All you had to do wass follow the press to learn the progress of the FDA’s actions. On 3/19, preliminary to an FDA Drug Advisory meeting, the organization released a document containing its thoughts. Shortly afterward, a MedPage article headline proclaimed: “FDA Staff Not Thrilled About Opioid Implant.” 

It seems that during clinical trials, some people still needed oral Suboxone to ward off withdrawal symptoms, which in turn, meant that the company’s claims that implants would reduce pediatric exposure to the medication were not reliable. (The company said that with five rods, patients would receive a steady dose of medication for up to 4 to 6 months.)

Or, as Treatment Magazine’s editor succinctly put it, after reading the document: 

“Long-acting buprenorphine implants, already brand named Probuphine by Titan Pharmaceuticals as the tiny specialty pharma moves through trials and FDA approvals for the implantable opioid replacement therapy, got a decidedly negative review by FDA staffers in what is the key aspect of the implants - their ability to completely replace daily dosing and thus solve a range of thorny bup issues ranging from diversion to proper dosing and even the possibility of cutting back on the highway robbery $150 to $300 monthly doctor's visits.”

However, two days later, a Medscape article stated “FDA Panel Says a Cautious ‘Yes’ to Buprenorphine Implant.” The writer summarized the panel’s findings as follows:

“The vote was 10 to 4 (with 1 abstaining) that the efficacy, safety, and risk-benefit data supplied by the company supports approval.

The panel ‘seemed to agree that this is a product with great potential utility, but there is some deficiencies in terms of dosing and REMS (Risk Evaluation and Mitigation Strategies) but that overall need for a product such as this on the market exceeded those deficiencies,’ said panel chair Edward Covington, MD, from the Cleveland Clinic Foundation.”

(You might need to register on Medscape to read the article.) 

I know implants have been used for birth control for quite some time; it’s interesting to consider them for addiction treatment. You’d think that the convenience would be a big selling point for addicts, but the potential for abuse never occurred to me. And the safety question is troublesome, too. The FDA may have its critics, but it’s a good thing we have them to monitor new therapies

Joan added:  Detoxing clients from suboxone or subutex presribed for "long term" pain management is for the most part a long and agonizing ordeal.  The last 2 mg are especially difficult. I wrote about Krissie Bergo's detox from the suboxone here.  I wonder if the FDA took the end game into consideration.  Just what is it like to detox from a buprenorphine implant?  Or is the FDA expecting people to have the implant for life?  

You often hear that addiction  is an equal opportunity disease and truth be told, people from all walks of life end up in prison because of drugs, whether due to possession, dealing, or committing crimes to be able to buy them.

Here’s one statistic regarding the extent of the problem: A writer in the August issue of Perspectives, A Journal on Addiction Research and Public Policy (the journal's website is http://www.ncaddnj.org), said “there are more than two million jail and prison inmates, “and “about 15% have histories of heroin dependence.”

But inmates with a history of crimes not related to drugs have substance abuse problems, too. So it’s not surprising so many of those incarcerated try to have drugs smuggled in to them. What is surprising is the current drug of choice is Suboxone, a legal, synthetic opiate used to efficiently detox addicts off other opiiates such as heroin and oxycodone, also used for pain management.   Addicts who can afford the high cost sometimes use suboxone or subutex -- both medically known as buprenorphone -- instead of methadone to prevent opiate usage.

According to a New York Times article, friends and families of inmates (I assume that’s who the smugglers are) crush Suboxone pills into a paste and spread it on children’s artwork, spread it under stamps on inmates’ mail for them to lick, or tuck it behind envelope seams. Smugglers have even included it under pictures in kids’ coloring books.  The New York Times article further reports that suboxone has become a coveted contraband because it can provide a sense of euphoria.

The Cumberland County jail has a new rule that every piece of mail must come in a white envelope -- so officials can detect the orange tint of the suboxone strips when they hold the envelope up to the light.  At the Maine Correctional Center officials remove all mail from envelopes before delivering it to thwart suboxone smugging.  Any mail containing crayon scribblings, stickers, or glitter glue are not delivered.  In Massachusetts, suboxone makes up 12 percent of all contraband discovered in state prisons.

The Perspectives journal article writer noted that few inmates receive drug abuse treatment while incarcerated and are at high risk for relapse once they leave. (The New York Times cited a 2009 study in which only seven state prison systems were found to offer inmates Suboxone, and criticized the way it was done.) Some people would say well, at least there are seven. But this is yet another area where we as a nation need to improve.

Joan Borsten contributed to this article.