CNN: FDA approves device to wean addicts off heroin.
Read the full article here…http://www.cnn.com/2016/05/27/health/fda-approves-implant-to-treat-opioid-addicts/
The U.S. Food and Drug Administration has approved a drug-emitting implant to combat addiction to heroin and other opioids killing thousands of people annually.
The device is implanted in the arm and releases a steady dose of the medication buprenorphine (commonly known as Suboxone), which before had only been available as a pill, to curtail opioid cravings and prevent withdrawal symptoms over six months.
Suboxone can be abused because it can be taken in the way to provide the same feeling of euphoria as opioids.
Porcupine is supposed to deal with the diversion and overuse issues because it is implanted. As with other anti-addiction drugs, it is to be used in conjunction with behavioral treatment to help manage an addict’s recovery and ease withdrawal from opioid drugs.
The approval of the device, named Probuphine, “provides the first-ever implantable option” to help patients maintain treatment addiction. Advocates said because it is implanted it will ensure patients do not miss their daily dose nor sell their supply to recreational users or other addicts.
But the FDA views expanding medication-assisted treatment, currently, methadone, buprenorphine or naltrexone, as a cornerstone of its plan to decrease opioid overdose, death and dependence from heroin and opioids such as hydrocodone and oxycodone.
Two million Americans were dependent on prescription opioids in 2014, when the most recent data was available, federal statistics show.
Overdoses linked to opioids killed more than 28,000 people nationwide two years ago, according to the Centers for Disease Control and Prevention. The deaths include those involving heroin and prescription drugs such as oxycodone and hydrocodone.
Every 19 minutes, someone dies from an accidental overdose, the CDC reports.
Americans represent just 5% of the world’s population, but they consume 80% of the world’s opioids, according to the American Society of Interventional Pain Physicians.
Most drug overdose deaths — at least six out of 10 — involve an opioid, federal statistics show.
“Overdose deaths involving prescription opioids have quadrupled since 1999, and so have sales of these prescription drugs,” the CDC says.
The package insert says:
Probuphine is not appropriate for patients new to treatment and patients who have not achieved and sustained prolonged clinical stability on buprenorphine 8 mg per day or less of a sublingual tablet or generic equivalent. So to be eligible to receive it, patients have to be successful using the oral form of the drug for three months. If they are stable on the oral drug, why do they need the implantable form? I guess to avoid misuse, to make buprenorphine less available.
The implants should not be used for additional treatment cycles after one insertion in each upper arm. So if relapse is an issue, which it so often is, they are out of luck.
Patients who need more than 8mg/day are also out of luck, the implant gives that precise dose and is not recommended for patients on more than 8mg/day. They do not recommend tapering the dose to achieve the dose required.
They also recommended, for patients that do not have adequate results from the implant, occasional supplemental dosing with buprenorphine. In other words, use buprenorphine – oral drug – in addition. But doesn’t that defeat the purpose? I suppose a lesser oral dose decreases the amount of drug that is available for abuse, but addicts are sneaking, if they want more they will figure out a way to get it.
And then there is the issue of what to do at the end of treatment with the implant. Patients will go through withdrawal if the implant, and consequently the drug, is suddenly removed. So again, oral buprenorphine is recommended.
What do I think?
I think this is generally a good idea. I think it is great that we are trying to find better alternatives to the opiate/opioid addiction issue. We need to be focusing on improving the solution (as well as other things like stemming the flow of the drugs in the first place) and this idea is an interesting one.
I like the idea that by implanting the device, the likelihood of abuse decreases. It’s still possible of course, but making it much more difficult to alter the drug (they would have to remove the implants) would deter most addicts I would think. I am concerned, however, that the device will be removed by someone other than the doctor that inserted it. I think about infection in those who do not take care of themselves as they should. The implant isn’t tamper resistant, so that if the addict does remove it they are able to abuse the drug within.
I understand that in using this implant, the amount of buprenorphine available for misuse is decreased while the implant is in place, but misuse is not impossible. I see it as a temporary replacement of buprenorphine. Most successful cases of buprenorphine treatment of addiction require an addict to be treated with it for a very long time, not just a year. So if this implant can only be used for one year, it doesn’t really address the issue on a long term basis. Maybe when we have more data, longer treatment will be possible. We will have to wait and see.
Overall, it is good we are looking for alternative solutions, we must. Let’s not stop here, this is not a great solution, it is a good idea, one that will hopefully lead to better ideas in the near future.