FDA Panel Recommends Approval of Buprenorphine Implant to Treat Addiction

An advisory panel to the Food and Drug Administration (FDA) recommended Tuesday that the agency approve the buprenorphine implant Probuphine as a treatment for opioid addiction.

The FDA is not required to follow their advisory panels’ advice, but usually does so.

Probuphine provides a steady dose of buprenorphine, which eases withdrawal symptoms, decreases cravings and reduces the risk of relapse, according to USA Today. Buprenorphine is currently sold as a pill or dissolvable film placed under the tongue.

Patients can get buprenorphine at a doctor’s office. Physicians who prescribe the drug must be certified to dispense it. They are only permitted to treat 100 patients at the time, the article notes. Buprenorphine is generally considered to be safer than methadone, because it is less likely to cause an overdose, the newspaper reports. About one million people took buprenorphine in 2012, according to the FDA.

Probuphine consists of four rods the size of a matchstick that are implanted under the skin of the upper arm, in a procedure that takes about 10 to 15 minutes in a doctor’s office. It remains in place for about six months.

The FDA is considering approving the drug for stable patients who are already using dissolvable buprenorphine film at a low dose. The panel voted 12-5 in favor of Probuphine.

Tracy Rupp, Director of Public Health Policy Initiatives at the National Center for Health Research, urged the committee to reject Probuphine. She said Braeburn Pharmaceuticals, which makes the drug, presented only one clinical study that showed the drug’s effectiveness. Rupp said the study had multiple flaws.

The FDA panel’s Acting Chairwoman, Judith Kramer, said she voted against recommending Probuphine’s approval because it is not yet known whether the drug is effective for more than six months. Many people addicted to opioids require years of treatment, she said.

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    January 14, 2016 at 12:18 PM

    An interesting treatment option. The concept is similar to depot naltrexone but longer lasting. I hope questions will be answered through future use:

    1) expected duration of effective blood levels of buprenorphine
    a) will it be appropriate for long term MAT?
    2) ease of removal (Norplant was easy to insert but occasionally difficult to remove)
    3) efficacy of de novo treatment vs conversion from sublingual formulations of Bupe.

    These are just a few that come immediately to mind.

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