FDA Advisers: Approve Implant for Opioid Addiction
Jan. 13, 2016 -- An implant for opioid addiction should be approved by the U.S. Food and Drug Administration, an agency advisory panel of medical experts says.
Opioids include heroin and powerful prescription pain drugs such as hydrocodone (Vicodin), oxycodone (OxyContin, Percocet), morphine and codeine.
The implant is a rod about the size of a small matchstick that is placed in the arm and delivers daily doses of buprenorphine -- a drug widely used to treat opioid addiction -- for six months, The New York Times reported.
While the drug can help treat opioid addiction, buprenorphine can also be addictive. That risk is heightened because buprenorphine has to be taken by mouth, requiring patients to manage their daily doses.
In voting 12 to 5 Tuesday to recommend approval of the Probuphine implant, the advisory panel concluded it was about as effective as the oral form of buprenorphine and could help combat the national epidemic of drug overdoses, the Times reported.
"There is not evidence of significant risk using this agent, but there is evidence of significant benefit," Dr. Thomas Grieger, a staff psychiatrist at the Maryland Department of Health and Mental Hygiene, said.
Dr. David Pickar, adjunct professor of psychiatry at Johns Hopkins Medical School, said: "I think this will save some folks' lives. From a safety point of view I think we're in good shape."
There was a record number of opioid overdose deaths in the United States in 2014, according to federal health officials, the Times reported.
Among concerns expressed at the advisory meeting about the implant: there is no way to adjust the daily dosage delivered, and patients with the implant might not follow through with counseling and other important parts of treatment.
While not required to do so, the FDA typically follows the recommendations of its advisory panels.
The implant is made by Princeton, N.J.-based Braeburn Pharmaceuticals.