FDA Approves Probuphine Implant for Opioid Dependence

Share this content:
FDA Approves Probuphine Implant for Opioid Dependence
FDA Approves Probuphine Implant for Opioid Dependence

THURSDAY, May 26, 2016 (HealthDay News) -- 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. 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. 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.

More Information

Share this content:

is free, fast, and customized just for you!

Already a member?

Sign In Now »


Sign up for myCME e-newsletters


Drug Lookup

Browse drugs by: BrandGenericDisease

Trending Activities

All Professions

More in Home

ASCO: Moderate Activity Tied to Longer Survival in Advanced CRC

ASCO: Moderate Activity Tied to Longer Survival in ...

Patients only appeared to derive benefit from moderate -- not vigorous -- activity

Number of Infants Born to Women Using Opioids Up Sharply

Number of Infants Born to Women Using Opioids ...

Few treatment programs deal with substance abuse in expectant moms, federal report says

Hypertension Onset After Age 80 May Protect Against Dementia

Hypertension Onset After Age 80 May Protect Against ...

Association independent of antihypertensive medication use

is free, fast, and customized just for you!

Already a member?

Sign In Now »