opiate addiction

Should FDA Approve An Implant to Treat Opiate Addiction

Drug abuse and addiction problems may not be new for our country, but the primary source of these problems has changed.  Where once illicit drug substances like heroin, cocaine and methamphetamine seemed to cause the greatest harm, it is now doctor-prescribed painkillers that are the greatest threat to the health and welfare of our nation’s citizens.  The National Institute on Drug Abuse has confirmed that more individuals now die from prescription drug overdoses than from heroin and cocaine overdoses combined.  The epidemic of prescription drug abuse and addiction has thrown many communities, states, lawmakers and law enforcement officials into high alert, searching for ways to change and end this deadly trend.  Some are wondering if an implant that treats opiate addiction may be the solution–while others are wondering if it may only compound the problem.

About Probuphine

Probuphine is an implant that would provide an opiate addict with a steady dose of buprenorphine, an opiate drug that has been shown to help ease withdrawal symptoms, decrease cravings and reduce the risk of a relapse.  Currently, this drug is only available in pill form or as a dissolvable film that is placed under the tongue.  The problem is that like every other prescription drug that has come before it, buprenorphine use comes with big risks and side effects.  As an opiate drug itself, buprenorphine can cause tolerance and addiction issues, especially when addicts abuse it by taking more than intended.  Some addicts may even sell the drug so they can buy more of the opiates they are addicted to.  Braeburn Pharmaceuticals, probuphine’s manufacturer, is arguing that an implantable drug will eliminate these risks.

The probuphine implant being considered for FDA approval works much like a contraceptive implant.  Four small, implanted rods that take roughly ten to fifteen minutes to implant and roughly twenty minutes to remove provide the individual with a steady amount of buprenorphine for up to six months.  The FDA is looking at restricting its approval of this drug–to those stable patients who are currently taking low doses of the dissolvable buprenorphine film.  And while there are many who believe this new drug may help solve the opiate addiction problem for many, there are others who are far more skeptical.

Pharmacist Tracy Rupp is one such skeptic, urging the FDA committee to reject probuphine considering they have only been presented with one clinical study regarding the drug’s effectiveness.  The study compared probuphine implants and buprenorphine film in stable patients who had safely and successfully been using the film.  After six months, it was found that eighty-five percent of participants who had been given probuphine tested negative for illegal drug use, and seventy-two percent of participants who had been given the buprenorphine film tested negative for illegal drug use.  While this may seem promising, Rupp argued that the study had flaws.  For example, some missing urine tests were counted as negative, when it’s possible participants were skipping tests in order to avoid revealing positive results.  Considering how close the results were between the implant and the film, these skipped tests could prove there was actually very little or even no difference at all between the two treatment methods.

The committee’s acting chairwoman also voted against recommending probuphine’s approval because there is no evidence to support whether the implant is still effective after six months of use.  Past research and experience has indicated that opiate addicts often need to take medication for years in order to successfully recover from opiate abuse and addiction, and there’s no information yet about whether probuphine will be able to provide this continued support.

While there is no doubt that something must be done to help reverse the opiate addiction epidemic, it may be prudent to ensure that whatever the solution is, it doesn’t actually create a worse problem in the future.  Unfortunately, without further study, the opiate implant probuphine may be such a problematic solution.

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