FDA approves implant to treat opioid dependence

The implant proved to be as effective as other forms of buprenorphine used to treat opioid addiction, but may be more beneficial to patients because it is easier to use.
By Stephen Feller  |  May 27, 2016 at 12:04 PM
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BETHESDA, Md., May 27 (UPI) -- The U.S. Food and Drug Administration approved the first implant for treatment of opioid dependency, a six-month treatment of low-level buprenorphine that may be more effective for patients because it is easy to use.

Probuphine is the first implantable delivery of buprenorphine, which is typically delivered by pill or dissolvable film placed under the tongue, which the agency said could be even more effective when paired with behavioral treatment and recovery support.

The implant consists of four small rods placed under the skin of the upper arm, slowly releasing buprenorphine over the course of six months. Unlike other drugs used for detoxification, including the pills or films, the implant prevents abuse of the drug.

"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," Dr. Nora Volkow, director of the National Institute on Drug Abuse at the National Institutes of Health, said in a press release. "This product will expand the treatment alternatives available to people suffering from an opioid use disorder."

In response to the epidemic of opioid abuse in the United States, the FDA has in recent months added warnings to the labels of opioid-based drugs about the potential for abuse and addiction.

At the same time, the agency has been considering approval of Probuphine since January, reviewing clinical trial data comparing the implant to other drugs used for opioid dependency, as well as other forms of buprenorphine.

In a trial with patients who already were being treated with low-dose buprenorphine, 63 percent of patients with the implant showed no evidence they'd used opioid drugs during the study, similar to the 64 percent of patients treated with the sublingual, or under-the-tongue, film in another study.

"The benefits seen through this model demonstrate the impact of sustained abstinence during treatment," Dr. Walter Ling, a professor of psychiatry and director of Integrated Substance Abuse Programs at the University of California Los Angeles, said in a press release. "An implantable formulation of buprenorphine could present physicians, patients and society with a new option that mitigates some risks associated with sublingual formulations. Patients may have decreased preoccupation with their ritual of taking medication daily, giving them freedom to focus on other parts of their recovery."

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