Buprenorphine Drug Scheduling Timeline
Buprenorphine was first marketed in America in 1985, it was then scheduled by the FDA as a Schedule V narcotic. The only available product in the United States at that time was a very low-dose formulation intended for injection.
It was sold under the brand name Buprenex®. The FDA said that diversion, abuse & trafficking was occurring in Europe and other parts of the world. Considering the strength of Buprenorphine, it doesn’t surprise me that it was misused and/or trafficked.
Anyone who has attempted to stop taking Buprenorphine (aka Suboxone) knows how difficult it can be, sometimes more difficult than quitting other addictive opiates. If you are trying to taper from an addictive opiate or suboxone, you can check out the suboxone taper calculator on this site, or check out the new one on http://warm-turkey.com/HalfLife
Subutex and Suboxone were approved by the FDA in 2002 as schedule III Narcotic
The Food and Drug Administration (FDA) approved two buprenorphine products (Suboxone® and Subutex®) for the treatment of opioid addiction.
Both products are high dose (2 mg and 8 mg) sublingual (under the
- Subutex® is a single entity buprenorphine product
- Suboxone® is a combination product with buprenorphine and naloxone in a 4:1 ratio, respectively.
DEA Places Burprenorphine Products In Schedule III in 2002
The DEA placed buprenorphine and all products containing buprenorphine into schedule III in 2002. Since 2003, diversion, trafficking and abuse of buprenorphine have become more common in the United States.
FDA Approves Extended Release Buprenorphine Product – Butrans® in 2010
In June 2010, FDA approved an extended release transdermal film containing buprenorphine (Butrans®) for the management of moderate to severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time.