Medication-assisted treatment (MAT) is the use of medications in combination with counseling and behavioral therapies, which is effective in the treatment of opioid use disorders (OUD) and can help some people to sustain recovery.

More must be done to facilitate treatment options and the development of therapies to address OUD as a chronic disease with long-lasting effects. This means helping more people secure MAT, which requires us to break the stigma often associated with some of the medications used to treat OUD. It also requires us to find new and more effective ways to advance the use of medical therapy for the treatment of OUD.

There are three drugs approved by the FDA for the treatment of opioid dependence: buprenorphine, methadone, and naltrexone. All three of these treatments have been demonstrated to be safe and effective in combination with counseling and psychosocial support. Everyone who seeks treatment for an OUD should be offered access to all three options as this allows providers to work with patients to select the treatment best suited to an individual’s needs. Due to the chronic nature of OUD, the need for continuing MAT should be re‐evaluated periodically. There is no maximum recommended duration of maintenance treatment, and for some patients, treatment may continue indefinitely.

FDA-approved buprenorphine products approved for the treatment of opioid dependence include:

Bunavail (buprenorphine and naloxone) buccal film
Cassipa (buprenorphine and naloxone) sublingual film
Probuphine (buprenorphine) implant for subdermal administration
Sublocade (buprenorphine extended‐release) injection for subcutaneous use
Suboxone (buprenorphine and naloxone) sublingual film for sublingual or buccal use, or sublingual tablet.
Subutex (buprenorphine) sublingual tablet
Zubsolv (buprenorphine and naloxone) sublingual tablets

Calvillo FDA-approved methadone products approved for the treatment of opioid dependence include:

Dolophine (methadone hydrochloride) tablets
Methadose (methadone hydrochloride) oral concentrate

Vị Thanh FDA-approved naltrexone products approved for the treatment of opioid dependence include:

Vivitrol (naltrexone for extended-release injectable suspension) intramuscular

• Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment (Draft Guidance for Industry)
• CDER Conversation: Treatment for Opioid Use Disorder
• Patient-Focused Drug Development Meeting on Opioid Use Disorder
• Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment (Final Guidance for Industry)
• FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks
• Neonatal opioid withdrawal syndrome and medication-assisted treatment with methadone and buprenorphine

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Announcements

• FDA in Brief: FDA finalizes new policy to encourage widespread innovation and development of new buprenorphine treatments for opioid use disorder
• FDA approves new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence
• FDA takes new steps to encourage the development of novel medicines for the treatment of opioid use disorder
• FDA approves first generic versions of Suboxone sublingual film, which may increase access to treatment for opioid dependence
• FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults
• FDA takes new steps to advance the development of innovative products for treating opioid use disorder
• Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to encourage more widespread innovation and development of new treatments for opioid use disorder
• Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to promote the safe adoption of medication-assisted treatment for opioid addiction
• FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder
• Statement from FDA Commissioner Scott Gottlieb, M.D., on the approval of a new formulation of buprenorphine and FDA’s efforts to promote more widespread innovation and access to opioid addiction treatments
• FDA approves first buprenorphine implant for treatment of opioid dependence

Additional Resources

• HHS: Treatment for Opioid Use Disorder
• SAMHSA: Medication-Assisted Treatment