History of Probuphine
As it contains the active ingredient buprenorphine, Probuphine is a Schedule III controlled substance. This Drug Enforcement Administration classification is because although therapeutic when used accordingly, buprenorphine has the potential to be abused if used inappropriately.
As a sublingual (under the tongue) tablet, buprenorphine was initially approved by the FDA in 2002. Since then, many studies have shown substantial benefit of using buprenorphine in supporting recovery from opioid addiction.
Probuphine is the implant formulation of buprenorphine created by Titan Pharmaceuticals. It was FDA approved for the treatment of opioid dependence in 2016 and is eligible for use in individuals between the ages of 16 and 65.
Probuphine is the only implant medication approved in the treatment of opioid dependence. The implant formulation was designed to allow for the continuous and stable release of buprenorphine without the associated clinic visits or risk of inconsistent dosing.
The benefits of using Probuphine over other formulations include:
- Lower risk of diversion compared with daily formulations
- Sustained release of medication leading to non-fluctuating blood levels
- Greater adherence in comparison with oral and transdermal formulations
- Convenience (no need for daily treatment because implant is every six months)
- Fewer office visits (required only once per month to inspect implant area)
- Less possibility of misuse or incorrect use
Probuphine for Opioid Addiction
Probuphine is used for the maintenance treatment of opioid-dependent patients already on a maintenance dose of 8 mg or less of submucosal or sublingual buprenorphine.
Probuphine is not appropriate for individuals new to opioid treatment plans. Individuals who have not yet achieved a sustained, prolonged clinical stability on oral formulations are not eligible for Probuphine treatment. Clinical stability with submucosal or sublingual buprenorphine is required prior to the commencement of Probuphine.