FDA Approves Innovative Sustained-Release Drug Implant to Control Addiction
FDA approves innovative sustained-release drug delivery implant to control opioid dependence for up to 6 months.
HealthDay News — The U.S. Food and Drug Administration (FDA) 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. 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 the United States 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. 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.