The U.S. Food and Drug Administration has approved the first-ever buprenorphine implant to treat opioid dependence, the agency said Thursday in a news release.
Up to now, the drug buprenorphine has only been available in pill or film form to be placed under a person’s tongue, the FDA said. Probuphine, which provides a constant, low-level dose of the drug, is designed to last six months.
Earlier this year, an FDA advisory committee of experts recommended Probuphine’s approval, the agency said.
The drug, combined with behavioral therapy, can combat opioid addiction without “causing the cycle of highs and lows associated with opioid misuse or abuse,” and can make the addictive qualities of opioid use less attractive, the FDA said. The agency cited U.S. government statistics that opioid addicts receiving this combined therapy cut their risk of death from all causes by half.
Probuphine’s four one-inch rods are surgically implanted under the skin of the upper arm. If additional treatment is needed, a second set of rods may subsequently be implanted in the opposite arm. The agency said it has ordered post-marketing studies of the safety and effectiveness of this additional course of treatment.
Sixty-three percent of people who used Probuphine had no evidence of illicit opioid use throughout the six months of treatment, the agency said.
The label includes a boxed warning of potential dangers during the product’s insertion or removal, the FDA said. These include the potential risks of implant protrusion and nerve damage.
Probuphine is marketed by San Francisco-based Titan Pharmaceuticals and Princeton, N.J.-based Braeburn Pharmaceuticals.
Learn more from the FDA.
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