He added: “Opioid abuse and addiction have taken a devastating toll on American families”.
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“We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives”, said FDA Commissioner Robert M. Califf, M.D.
Sheldon said the company is exploring “value-based reimbursement programs” that would provide insurers with rebates if the overall cost of care for a group of patients on Probuphine exceeded the cost of treatment either for the same patients in a prior six-month period or for a comparable group of patients taking other forms of buprenorphine or other anti-addiction medication.
The Food and Drug Administration on Thursday approved the first implantable drug to deliver long-lasting medication to people addicted to opioids, such as OxyContin and heroin.
Previously, buprenorphine to treat opioid dependence was allowed just as a pill or a film positioned under the tongue or on the inside of the cheek of an individual until it gets dissolved.
Photo by The Associated Press/Times Free Press.
A clinical study involving 175 people tested the implant.
“It really reduces or eliminates cravings, and they don’t start searching around for opiates”, said Dr. Scott Segal, president and chief medical officer of the Segal Institute for Clinical Research in Miami, one of the centers that participated in the clinical trials.
The implant administers buprenorphine for up to six months after users have been stabilized on the oral form of the drug. “You miss your doctor’s appointment, the pharmacy doesn’t have the medication and there’s problems. The implant takes away that decision”. In addition to the cost, critics consider the buprenorphine arm implant to be largely unproven.
The most common side effects from treatment with Probuphine include implant-site pain, itching, and redness, as well as headache, depression, constipation, nausea, vomiting, back pain, toothache and oropharyngeal pain. “The patients enrolled quickly”.
The first-ever implant used to treat opioid addiction won approval from federal regulators Thursday, providing yet another weapon in the battle against an epidemic of opioid use. According to the CDC, deaths from opioid overdoses reached a record 28,647 in 2014. With 78 people in the US dying each day from opioids, it’s important that patients have more treatments to choose from as no one option will work for everyone.
“Scientific evidence suggests that maintenance treatment with these medications in the context of behavioral treatment and recovery support are more effective in the treatment of opioid use disorder than short-term detoxification programs aimed at abstinence”, said Nora Volkow from the NIH.
There is a stigma about treating addiction with medication that can be hard to overcome for many users. Probuphine must be prescribed and dispensed according to the Probuphine REMS program because of the risks of surgical complications and because of the risks of accidental overdose, misuse and abuse if an implant comes out or protrudes from the skin.
“It tends to saturate the receptors that respond to opiates”, he said. “It provides pain relief, but doesn’t give them the buzz or high that heroin would”.
And unlike with oral forms of the drug, there would be no risk of it being sold illegally on the street or accidentally ingested by children in a household. Relatively few buprenorphine prescriptions are written by doctors with surgical training, the report said.
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The intent is most likely to help other people quit their drug habit, Umbricht said, but without drug counseling those addicts are not likely to succeed.
