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Is Suboxone FDA approved for chronic pain?

No, Suboxone (buprenorphine/naloxone) is not FDA approved for chronic pain. However, many medications prescribed by doctors in the United States are used "off-label" (for a purpose other than their FDA approval). Some doctors prescribe Suboxone off-label for chronic pain. 

There is a patch form of buprenorphine called Butrans that has been FDA approved for the treatment of chronic pain. 

Health care providers are increasingly prescribing Suboxone and other buprenorphine-containing medications like Butrans  for chronic pain, both in people with and people without a  concurrent diagnosis of opioid use disorder .

This means that many patients who do NOT use opioid medications are using buprenorphine for their pain, because it is in many ways a safer long-term alternative to opioids.

What Is Butrans?

Butrans is a transdermal buprenorphine patch that is used to treat high-level, chronic pain.[1] Buprenorphine is the primary ingredient in Suboxone, and Butrans and Suboxone have similar effects on brain chemistry and pain-perception

This patch is not used for common or acute pain. Instead, it is used to treat pain that occurs consistently and is severe. It is generally only used after other pain management options have proven ineffective. 

Since Butrans is a long-acting medication, it is prescribed to those with pain that requires constant management, such as pain associated with arthritis or serious back issues. 

As with all opioids, it is best to use the lowest possible dose of buprenorphine that still controls the pain.. Generally, patients will be prescribed an initial low dose. If that doesn’t control pain, the dose will be raised in a slow and methodical fashion.

As a transdermal patch, Butrans is applied to the skin and left on for a week. The patch is available in different dosage levels, designated as micrograms per hour, ranging from 7.5 to 20.[2] 

While Suboxone is one of the primary buprenorphine-based choices for Medication for Addiction Treatment (MAT), Butrans is not typically used for opioid use disorder treatment. 

Is Butrans Safe to Take for Chronic Pain?

When taken as prescribed, Butrans is safe to take for chronic pain. Like Suboxone, the primary ingredient in Butrans is buprenorphine, and it has been shown to be effective in managing chronic pain, particularly for those who haven’t been taking opioids.

Since Butrans has opioid activity, it is not a first-line treatment for pain. Doctors only prescribe it when other methods for pain relief, such as nonsteroidal anti-inflammatory medications or physical therapy prove ineffective.

Like all medications, Butrans comes with some potential side effects, including the following:[2]

  • Respiratory depression (slow or shallow breathing)
  • Constipation and other gastrointestinal issues
  • Rash or other skin reactions at the application site
  • Severely low blood pressure
  • Fatigue
  • Headaches

Certain people don’t meet the criteria to take Butrans. If you meet any of the following criteria, you should likely not use Butrans for chronic pain relief:

  • Liver problems
  • Seizures
  • Fever
  • Low blood pressure
  • History of substance misuse
  • Breathing issues
  • Severe intestinal problems
  • Muscle stiffness
  • Appetite loss 
  • Irritability

Talk to your doctor about other forms of chronic pain management if you have any of the above conditions.

Is Butrans Effective in Treating Pain?

Yes, Butrans can effectively manage chronic pain.

A meta-analysis of buprenorphine’s use for chronic pain concluded that it was effective in lessening overall pain intensity for patients without opioid use disorder (OUD).[3] For patients with OUD, its effect was only small, on average, whereas for those without OUD, the effect was moderate to large.

This difference in effect between those with OUD and those without is likely tied to  the tolerance that occurs when people are taking opioids on a daily basis, such as is seen in people with OUD. Since people with OUD regularly use opioids, the effects of Butrans for pain relief won’t be as strong as they will be for someone who is opioid-naïve.[4]  

It’s unlikely  you would be prescribed Butrans for OUD treatment. If you are, it’s imperative that you work with your physician and your recovery support team and to only use the buprenorphine patch as prescribed.

Are Other Forms of Suboxone Used for Pain Treatment?

Suboxone is not FDA-approved for the treatment of pain. Suboxone and its generic forms are only FDA-approved to treat opioid use disorder.[5] 

In addition to the transdermal patch, Butrans, Buprenex is an injectable form of buprenorphine that is approved for the treatment of chronic pain.[6] As with Butrans, Buprenex’s primary ingredient is buprenorphine. It does not contain naloxone.[7]

The naloxone in Suboxone serves as an abuse-deterrent. Some argue that it would be wise to add naloxone to the FDA-approved versions of buprenorphine used to manage chronic pain, particularly for those with a history of OUD. Currently, the accepted recommendation is that those with a history of OUD do not use Butrans or other buprenorphine-only medications to manage chronic pain.[8]

Further studies on the use of buprenorphine alone (as in Butrans and Buprenex) versus a combination of buprenorphine and naloxone (as in Suboxone) are needed to assess each version’s effectiveness and risk profile for managing chronic pain in those who are not opioid-naïve.   

Suboxone is still prescribed off-label to treat pain in some instances. However, studies show that it does not provide robust pain relief in people with chronic pain.[9]  

SOURCES

  1. Information About the 7-Day Butrans Patch. Butrans. https://butrans.com/patient/home.html. Accessed March 2022.
  2. What Is Butrans? Butrans. https://butrans.com/patient/what-is-butrans.html. Accessed March 2022.
  3. Is Buprenorphine Effective for Chronic Pain? A Systematic Review and Meta-Analysis. Pain Medicine. https://pubmed.ncbi.nlm.nih.gov/32330264/. December 2020. Accessed March 2022.
  4. Use of the Low-Dose Buprenorphine Patch: A Review. Journal of Palliative Medicine. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3991960/. April 2014. Accessed March 2022.
  5. FDA Approves First Generic Versions of Suboxone Sublingual Film, Which May Increase Access to Treatment for Opioid Dependence. U.S. Food & 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 March 2022.
  6. Buprenorphine With Naloxone for Chronic Pain. Practical Pain Management. https://www.practicalpainmanagement.com/treatments/pharmacological/opioids/buprenorphine-naloxone-chronic-pain. June 2014. Accessed March 2022.
  7. Buprenex. U.S. Food & Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018401s025lbl.pdf. October 2019. Accessed March 2022. 
  8. Understanding Buprenorphine for Use in Chronic Pain: Expert Opinion. Pain Medicine. https://academic.oup.com/painmedicine/article/21/4/714/5699282. April 2020. Accessed March 2022.
  9. Buprenorphine-Naloxone Therapy in Pain Management. Anesthesiology. https://pubs.asahq.org/anesthesiology/article/120/5/1262/13748/Buprenorphine-Naloxone-Therapy-in-Pain-Management. May 2014. Accessed March 2022.

Medically Reviewed By Claire Wilcox, MD

Claire Wilcox, MD, is a general and addiction psychiatrist in private practice and an associate professor of translational neuroscience at the Mind Research Network in New Mexico; and has completed an addictions fellowship, psychiatry residency, and internal medicine residency. Having done extensive research in the area, she is an expert in the neuroscience of substance use disorders. Although she is interested in several topics in medicine and psychiatry, with a particular focus on substance use disorders, obesity, eating disorders, and chronic pain, her primary career goal is to help promote recovery and wellbeing for people with a range of mental health challenges.

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