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What Is Probuphine?

Probuphine is a buprenorphine-containing implant developed for maintenance treatment of opioid dependence in clinically stable patients. It consists of small, flexible rods placed beneath the skin of the upper arm to release buprenorphine gradually. Probuphine was commercially discontinued in the United States in 2020, although the FDA approved updated prescribing information in December 2025. The implant was intended for patients who had already achieved sustained stability on low-to-moderate doses of transmucosal buprenorphine. It was not designed for patients beginning opioid use disorder treatment.

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What Is Probuphine?

Probuphine is a buprenorphine-containing implant developed for maintenance treatment of opioid dependence in clinically stable patients. It consists of small, flexible rods placed beneath the skin of the upper arm to release buprenorphine gradually. Probuphine was commercially discontinued in the United States in 2020, although the FDA approved updated prescribing information in December 2025. The implant was intended for patients who had already achieved sustained stability on low-to-moderate doses of transmucosal buprenorphine. It was not designed for patients beginning opioid use disorder treatment.

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How Does Probuphine Work?

Probuphine releases buprenorphine, a partial agonist at mu-opioid receptors in the central nervous system. Buprenorphine helps reduce opioid withdrawal symptoms and cravings while producing less maximal mu-opioid receptor activation than full opioid agonists. The implant was designed to maintain relatively steady buprenorphine exposure over approximately six months. It was used as part of a treatment program that included counseling and psychosocial support. Buprenorphine can still cause physical dependence, respiratory depression, and dangerous interactions with sedating medications.

Who Was Eligible for Probuphine Treatment?

Probuphine's FDA-approved indication is maintenance treatment of opioid dependence in patients who achieved prolonged clinical stability while taking no more than 8 mg daily of Subutex or Suboxone sublingual tablets, or an equivalent transmucosal buprenorphine product. It was not intended for new patients, those requiring higher buprenorphine doses, or patients with unstable symptoms. Treatment involved careful assessment of prior opioid use disorder therapy, adherence, withdrawal symptoms, and overall stability. Probuphine's commercial discontinuation limits its practical availability despite subsequent FDA labeling updates.

How Was Probuphine Administered?

Probuphine treatment involved inserting four buprenorphine-containing implants beneath the skin on the inner side of the upper arm. The implants were intended to remain in place for six months and had to be removed by the end of that period. Insertion and removal required specially trained, certified healthcare professionals operating under a restricted Risk Evaluation and Mitigation Strategy program. The implants were not available through ordinary retail pharmacy dispensing. Patients required follow-up assessments of implant placement, opioid withdrawal symptoms, and treatment stability. Implant replacement or transition to another medication required specialist planning.

What Are the Side Effects and Warnings of Probuphine?

Common adverse effects included implant-site pain, itching, redness, headache, constipation, nausea, and vomiting. Probuphine carries a boxed warning for serious complications associated with insertion and removal, including implant migration, protrusion, expulsion, and nerve damage. Improper placement can injure blood vessels or nerves, and expelled implants create a risk of accidental pediatric exposure. Buprenorphine can cause respiratory depression, particularly when combined with benzodiazepines, alcohol, or other sedatives. Other concerns include dependence, withdrawal, liver problems, and neonatal opioid withdrawal syndrome. Serious breathing difficulties or implant-related complications require urgent medical attention.

Common Questions About Probuphine

Is Probuphine the same as buprenorphine?

Probuphine contains buprenorphine in a long-acting implant formulation. Other buprenorphine products have different doses, routes of administration, and approved uses.

Is Probuphine still available in the United States?

Probuphine was commercially discontinued in 2020. The FDA subsequently approved updated labeling in December 2025, but this does not establish that the implant is currently commercially available.

How long did Probuphine implants last?

Four Probuphine implants were designed to release buprenorphine over six months. The implants had to be removed by the end of the sixth month.

Was Probuphine used for new opioid addiction treatment patients?

No. Probuphine was intended only for patients who had already achieved sustained clinical stability on low-to-moderate doses of transmucosal buprenorphine.

References

A Six-Month Randomized Controlled Trial of Probuphine Safety and Efficacy in Opioid Addiction. ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT01114308. Date Accessed November 2, 2026.

Buprenorphine Implants for Treatment of Opioid Dependence: A Randomized Controlled Trial. JAMA. https://pubmed.ncbi.nlm.nih.gov/20940383/. Date Accessed November 2, 2026.

Effect of Buprenorphine Implants on Illicit Opioid Use Among Abstinent Adults With Opioid Dependence Treated With Sublingual Buprenorphine: A Randomized Clinical Trial. JAMA. https://pubmed.ncbi.nlm.nih.gov/27434441/. Date Accessed November 2, 2026.

PROBUPHINE (Buprenorphine) Implant Prescribing Information. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/204442s015lbl.pdf. Date Accessed November 2, 2026.

Probuphine REMS Program. Probuphine REMS. https://probuphinerems.com/. Date Accessed November 2, 2026.