Probuphine Implants in the upper arm that release buprenorphine, a drug that counteracts opioid withdrawals and cravings, have proven effective in treating addiction to heroin and prescription painkillers.
Probuphine is steadily making its way through clinical trials, as well as the approval process of the U.S. Food and Drug Administration (FDA). Advocates of the drug suggest it might be the future of opioid treatment.
With an estimated 2.1 million people in the United States suffering from substance use disorders related to prescription opioids, like heroin and prescription painkillers, healthcare professionals are paying close attention.
Buprenorphine binds to the same receptors in the brain as opioids, essentially blocking the “high,” and it sells under the name Subutex and Suboxone, a Naloxone and buprenorphine mixture.
Buprenorphine received FDA approval for opioid treatment in 2002. Though it’s very effective, the medication, which comes in pill form, presents several problems.
What are Possible Problems with Buprenorphine?
While Buprenorphine has many benefits, there are some potential downsides.
1. First, there is the possible potential for abuse. Consuming too much of the medication can result in an overdose, although increasing the dosage does not intensify the effects like other opioids, so this isn’t common.
Anyone taking it can choose to stop at any time, which dramatically increases the likelihood of relapse, or the pills can be sold on the black market.
2. There are also regular doctor visits, trips to the pharmacy and the simple issue of remembering to take the medication on a daily basis. “The problem,” Joe. R. Gay, director of a nonprofit treatment agency in Ohio, told The New York Times, “is people are using buprenorphine to manage their addiction, not to recover from it.”
The Advantages of Probuphine
Buprenorphine works well for many people when used as directed, but can cause problems when not used correctly.
Enter Probuphine, which once implanted in the upper arm delivers up to six months of buprenorphine and eliminates much of the potential for abuse and misuse.
The research that Titan and Braeburn Pharmaceuticals, the makers of probuphine, submitted in the most recent FDA hearing shows positive results. The study involved 176 patients, half of which received the real implant and the other half a placebo.
Of those with probuphine, 88 percent tested negative for illicit opioids compared to 72 percent of those with the placebo implant.
Scott Jernigan, a 52-year-old husband, father of two, and successful businessman in Florida, lost all of those “identifiers” after a failed back surgery left him addicted to Oxycontin.
In a stroke of luck, Jernigan tells Buzzfeed News, he got into a clinical trial. At the latest FDA hearing, he shared his experience with probuphine.
“What the implant does is take away the reminder of how I screwed up every day, and the worry about missing my medication. Jernigan added, “I’m president of my own company again, I’m not a dirty junkie. But I need help. With the implant it will be one less hurdle for us addicts to get over.”
Despite Some Criticism, the FDA Approved Probuphine
Along with all the probuphine praise, however, comes valid criticism. The Director of Public Health Policy Initiatives at the National Center for Health Research, Dr. Tracy Rupp, spoke at the FDA hearing.
She voiced her concerns about the probuphine study, suggesting that it could take weeks for the implants to deliver proper levels of buprenorphine, which would put opioid dependent people at risk for relapse.
In an interview with The Daily Beast, Dr. Rupp said, “The probuphine implant was studied in only 87 patients for 6 months. This is not a large enough study to get a good understanding of the risks posed by this new form of treatment, nor is it of sufficient duration to understand the risks involved in placing a new implant every 6 months, in some cases for years.”
Others at the FDA hearing worried that people in the throes of addiction might relapse despite the presence of the implant, which could pose serious health risks. Some even wondered if desperate opioid users might even attempt to rip the implant out of their arm.
Despite fears surrounding the implant, the FDA’s advisory committee recommended that the agency approves probuphine.
“I think this will save some folks’ lives,” Dr. David Pickar, a member of the advisory committee and adjunct professor of psychiatry at John Hopkins Medical School, said to the New York Times. “From a safety point of view, I think we’re in good shape.”
Suboxone has been one of the most effective ways to manage opioid misuse, and offers those with an addiction to heroin and opiates get the quality of their life back. It will be interesting to see if Probuphine takes the management of addiction to the next level.