In 2002, Suboxone was approved by the U.S. Food and Drug Administration (FDA) for the treatment of opioid use disorder (OUD). For 20 years, Suboxone has helped people deal with cravings, relapse triggers, and withdrawal symptoms.
But Suboxone’s history is a little more complicated (and interesting) on a deep dive. Here is a timeline of its history:
- 1970s: Buprenorphine and naloxone are developed.
- 1981: Buprenorphine is approved as a painkiller.
- 2002: Buprenorphine and naloxone combination (Suboxone) is approved by the FDA.
- 2018: A generic form of Suboxone film is approved.
How Did Suboxone Start?
Two active ingredients are included in Suboxone, and both were developed decades ago.
In the 1970s, researchers looked for painkilling solutions with a higher safety profile. Chemists created buprenorphine, a partial opioid agonist, with teh goal of creating a safer alternative for pain control. 
In 1981, the FDA approved buprenorphine as a painkiller.
In 1971, the FDA approved naloxone for treating opioid overdoses. The heroin crisis was just beginning, and researchers felt confident that this medication would help to save lives.
In 2002, a medication containing buprenorphine (Subutex) was approved for OUD treatment. At the same time, a medication combining buprenorphine and naloxone (Suboxone) was approved.
- Buprenorphine. Drug Enforcement Administration. https://www.deadiversion.usdoj.gov/drug_chem_info/buprenorphine.pdf. May 2022. Accessed September 2022.
- Suboxone: Rationale, Science, Misconceptions. The Ochsner Journal. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5855417/. 2018. Accessed September 2022.
- Buprenorphine and the Opioid Crisis: A Primer for Congress. Congressional Research Service. https://sgp.fas.org/crs/misc/R45279.pdf. December 2018. Accessed September 2022.
- Naloxone. American Chemical Society. https://www.acs.org/content/acs/en/molecule-of-the-week/archive/n/naloxone.html. May 2016. Accessed September 2022.
- FDA Approves First Generic Versions of Suboxone Sublingual Firm, Which May Increase Access to Treatment for Opioid Dependency. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-versions-suboxone-sublingual-film-which-may-increase-access-treatment. June 2018. Accessed September 2022.
Medically Reviewed By Elena Hill, MD, MPH
Elena Hill, MD; MPH received her MD and Masters of Public Health degrees at Tufts Medical School and completed her family medicine residency at Boston Medical Center. She is currently an attending physician at Bronxcare Health Systems in the Bronx, NY where ... Read More