[…] Last month, an FDA scientific advisory committee voted 12 to 5 in favor of a new approach: a six-month implant of buprenorphine for addicts who are “stable” in their recovery from prescription painkiller addiction. Called Probuphine, and developed by Titan Pharmaceuticals of California and Braeburn Pharmaceuticals of New Jersey, the implant buried in a patient’s upper arm will in theory deliver a six-month supply of the medication while limiting illicit sales.
“It sounds like a reasonably good option for someone in recovery to ‘get it and forget it’ so they don’t have to remember their medication,” addiction treatment expert Marc LaRochelle of Boston Medical Center told BuzzFeed News. “I wouldn’t give it to everyone, but it would be nice to have another option.”
The FDA had nixed the implant in 2013, overriding an earlier science panel vote for its approval, out of concern about a lack of safety data.
FDA scientists again voiced concerns again at last month’s hearing, which largely debated a Braeburn-funded study finding the implant performed at least as well as the other approved forms of the drug in 176 addicts. […]
At the same hearing, Braeburn representatives suggested that only 14% of the implant patients relapsed into illicit drug use during the trial, compared with 28% of daily pill users. About 25% of people now prescribed low doses of buprenorphine to treat addiction after about six months of recovery — or about 400,000 addicts — could benefit from implants, the company says.
But the implant users ended up taking more medication overall than the daily drug users, pharmacologist Tracy Rupp of the National Center for Health Research testified, in a critique. That’s likely because it might take up to four weeks for the implant’s medication to kick in, she said, and the patients required extra medication until that happened. Doctors mishandling the transition from daily doses of buprenorphine to the implant might leave recovering addicts suddenly vulnerable to relapse. […]
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