At the end of this week, the Food and Drug Administration (FDA) approved the first Probuphine implant treatment for opioid addiction. The drug will be embedded to provide long-lasting medical treatment to people dependent on opioids like heroin and OxyContin.
Robert M. Califf, FDA Commissioner, said they have approved “the first-ever implantable option” as a support for patients who are going through a recovery program.
The four rods implant called Probuphine will be inserted under the arm and a continuous dose of buprenorphine (anti-addiction drug) will be administered over a period of six months.
Currently, the anti-addiction drug sells as a pill or a film that dissolves under the tongue. The Probuphine implant will be set for people who are already on low doses of buprenorphine and are stable.
The treatment has ignited much debate. Those in favor of the drug treatment welcome the implant as a new tool for the limited managements of opioid addiction. The critics agree the buprenorphine implant is a largely unproven cure that could have a huge price tag.
FDA advisor, psychiatrist David Pickar said the approval for the implant is an applauded action first of all because this type of treatment eliminates the issue of people not taking their medication, which seems to be a crucial problem. Other advantages come with the fact that the drug cannot be abused, resold or ingested accidently.
Other critics, including Judith Kramer, former committee advisor and professor emeritus of medicine at Duke University (School of Medicine) have argued against the decision of approval.
Kramer says the trial data for the implant showed the drug to be ineffective and unsafe. A few participants needed increased doses of buprenorphine for relief, which indicated the established doses are too small and couldn’t remove pill medication altogether.
The Probuphine implant treatment comes at a time when drug abuse has reached epidemic proportions in the US. According to the Centers for Disease Control and Prevention (CDC), in the year, 2014 deaths caused by opioid overdose reached a record number of 28,647. Car accidents kill fewer Americans than drug overdoses.
To insert and remove the Probuphine implant doctors need to follow a special training; 2,250 health-care providers are already signed up.
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