After being inserted into a patient’s upper arm, this implantable device delivers low-level doses of buprenorphine for six months.
The U.S. Food and Drug Administration, following a nationwide clinical study by researchers at the Mount Sinai Health System, recently approved the first implantable form of buprenorphine—a drug used to treat opioid addiction. The implant, called Probuphine, delivers low-level doses of the medication for six months after being inserted under the skin on the inside of a patient’s upper arm.
The clinical trial, led by Richard N. Rosenthal, MD, Medical Director of Addiction Psychiatry at Mount Sinai Behavioral Health System, found that more patients using the implant device—consisting of four one-inch-long rods—did not relapse, compared with those who took the buprenorphine orally, once a day. The results were based on a sample of 177 participants at 21 sites in the United States.
Opioids are a class of drugs that relieve pain and include oxycodone, hydrocodone, codeine, morphine, and fentanyl. The repeated use of opioids increases a person’s tolerance.
Expanding the use and availability of medication-assisted treatment options such as Probuphine is an important component of the federal government’s goal to reduce prescription opioid and heroin-related overdose, death, and dependence in the midst of a national epidemic.
The number of prescriptions filled for opioid pain relievers has increased dramatically over the years. According to the U.S. Centers for Disease Control and Prevention, more people died from drug overdoses in 2014—primarily prescription opioids and heroin—than in any other year on record.
By providing continuous dosing, the new implant eliminates a frequent problem among opioid addicts who do not take recovery medication as instructed by their doctors, which leads to relapse. Additionally, the implant eliminates
the drug’s accidental use by
children. Probuphine is recommended as part of a comprehensive treatment plan that includes counseling and psychosocial support.
“The opioid epidemic has such a negative impact on people and their families, as well as our culture and economy,” says Dr. Rosenthal, who is also a Professor of Psychiatry at the Icahn School of Medicine at Mount Sinai. “There’s a stigma. People think it’s bad behavior and that you should pull yourself up by your bootstraps. But painkiller addiction is a brain disease that needs medical treatment. We need more medications to treat this disorder.”
According to the National Institute of Drug Abuse of the National Institutes of Health, medicine given as a maintenance treatment in combination with recovery support is more effective than short-term detoxification programs aimed at abstinence.
“There’s probably a large untapped population of people being seen in primary care and elsewhere for whom this medication may be an excellent solution,” says Dr. Rosenthal. He adds that additional research is needed among broader populations of patients and to address the rate and predictors of relapse after the six months of implant use is discontinued.
Through the Center for Addictive Disorders and The Friedman Brain Institute, the Mount Sinai Health System treats at least 8,000 drug addiction patients annually, of whom 6,300 receive help for opioid addiction.