Information about Medications for Opioid Use Disorder (MOUD)

It is estimated that over 6.1 million people aged 12 or older have an opioid use disorder (OUD). Medications for opioid use disorder (MOUD) are an effective treatment of OUD. FDA is working to facilitate treatment options and develop therapies to address OUD, promote treatment awareness, and expand treatment access.

• Timeline of Selected FDA Activities and Significant Events Addressing Substance Use and Overdose Prevention

Advancing Evidence-Based Treatment with MOUD

There are three medications approved by the FDA for the treatment of OUD: buprenorphine, methadone, and naltrexone. All three of these treatments have been demonstrated to be safe and effective. FDA is working to identify treatment needs, expand access to treatment of existing MOUD, and promote development of new options for evidence-based treatment for OUD.

• FDA approved new buprenorphine treatment option for Opioid Use Disorder
• FDA and Reagan-Udall Foundation host public meeting on Considerations for Buprenorphine Maintenance and Care
• FDA and SAMHSA issue letter clarifying requirements for prescribing buprenorphine
• Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment (Draft Guidance for Industry)

Promote MOUD Treatment Awareness

FDA is actively involved in efforts to promote increased awareness of how providers can treat opioid use disorder, including MOUD. The campaign, Prescribe with Confidence: Patients with Opioid Use Disorder Need You, encourages providers from a variety of primary care practice settings to screen for OUD and to manage OUD collaboratively with patients the same way they collaborate on the care of other chronic conditions like asthma, diabetes, or hypertension.

• FDA recommends changes to labeling for transmucosal buprenorphine products indicated to treat opioid use disorder
• Providers, You Are the Missing Piece: Your Patients With OUD Need You. (MedPage Today, 2024)
• Prescribe with Confidence: Patients with Opioid Use Disorder Need You
• X-Waiver no longer required for buprenorphine prescribing for MOUD

FDA-approved MOUD

Buprenorphine:

• Brixadi (buprenorphine extended‐release) injection for subcutaneous use
• Sublocade (buprenorphine extended‐release) injection for subcutaneous use
• Suboxone (buprenorphine and naloxone) film for sublingual or buccal use
• Zubsolv (buprenorphine and naloxone) tablets for sublingual use
• Buprenorphine and naloxone tablets and film for sublingual or buccal use
• Buprenorphine tablets for sublingual use

Methadone:

• Methadone hydrochloride tablets for oral suspension
• Methadose (methadone hydrochloride) oral concentrate and tablets for oral suspension
• Methadone hydrochloride oral concentrate

Naltrexone:

• Vivitrol (naltrexone for extended-release injectable suspension) intramuscular

Related FDA Resources

• Prescribe with Confidence: Patients with Opioid Use Disorder Need You
• FDA approved the first generic application for naltrexone extended-release injectable
• FDA warns about dental problems with buprenorphine medicines and updates Medication Guide
• Opioid Medications
• FDA Overdose Prevention Framework
• Controlled Substances Program

External Resources

• SAMHSA: Medications for Substance Use Disorders
• SAMHSA: OUD Treatment Program Directory
• National Institute on Drug Abuse: Medication Treatment for Opioid Use Disorder
• Providers Clinical Support System (PCSS): Medications for Opioid Use Disorder
• CDC: Opioid Use Disorder: Preventing and Treating
• CDC: Linking People with Opioid Use Disorder to Medication Treatment