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Why was Subutex discontinued?

Medically reviewed by Sally Chao, MD. Last updated on May 27, 2021.

Official answer

by Drugs.com

Reckitt Benckiser Pharmaceuticals Inc., the manufacturer of Subutex (buprenorphine sublingual tablets), chose to discontinue the drug in the United States in 2011 after developing new formulations that were less likely to be abused. The U.S. Food and Drug Administration (FDA) determined that the drug was not taken off the market because of concerns about safety or effectiveness.

Subutex is still available in other parts of the world, and generic forms of sublingual buprenorphine are available in the United States.

Subutex is a brand name of buprenorphine, a drug approved by the FDA in 2002 as a treatment for opioid use disorder. Buprenorphine is a type of medicine called a partial opioid agonist. This means it binds to the body's opiate receptors but causes weaker effects than a full opioid agonist, like morphine. Buprenorphine is classified as a schedule III controlled substance because it has the potential to be abused and cause addiction.

Subutex was available as 2 mg or 8 mg sublingual tablets, meaning the tablet is placed under the tongue to dissolve rather than swallowed. Sublingual buprenorphine is often used in the initial stage of treatment for opioid use disorder.

There have been concerns that some formulations of opioids (including buprenorphine) can be abused by crushing the tablets and then snorting or injecting the powder. In response, drug manufacturers began to make opioid medications that included "abuse deterrents."

There are different ways to include abuse deterrents. One method is to combine an opioid with an opioid antagonist, such as naloxone. An opioid antagonist blocks all the effects of an opioid. Naloxone is not well absorbed from the stomach when taken by mouth, so it has no effect when the combined product is taken as recommended. But if the tablet was crushed in an attempt to abuse it, the naloxone would block the effects of the opioid.

The manufacturer of Subutex created drug formulations containing buprenorphine and naloxone, which would be more difficult to abuse than Subutex. When these became available, the company removed Subutex from the market in the United States in 2011.

References
  1. U.S. Food and Drug Administration (FDA). Subutex package insert. March 2021. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020732s024lbl.pdf. [Accessed April 22, 2021].
  2. Substance Abuse and Mental Health Services Administration (SAMHSA). Tip 63: Medications for opioid use disorder -- full document. May 2020. Available at: https://store.samhsa.gov/product/TIP-63-Medications-for-Opioid-Use-Disorder-Full-Document/PEP20-02-01-006. [Accessed April 21, 2021].
  3. U.S. Food and Drug Administration (FDA). Determination that Subutex (buprenorphine hydrochloride) sublingual tablets, equivalent 2 milligrams base and equivalent 8 milligrams base, were not withdrawn from sale for reasons of safety or effectiveness. February 13, 2015. Available at: https://www.federalregister.gov/d/2015-03001. [Accessed April 26, 2021].
  4. Indivior UK. Products. April 2020. Available at: http://www.indivior.com/products/. [Accessed April 22, 2021].

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