Approved Risk Evaluation and Mitigation Strategies (REMS)

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Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)
Shared System REMS
REMS last update: 05/23/2017

What are Buprenorphine Transmucosal Products for Opioid Dependence (BTOD) products?

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The Buprenorphine Transmucosal Products for Opioid Dependence (BTOD) REMS Program includes the following products:

Product Name Application Number Application Holder Added to REMS
Bunavail (buprenorphine and naloxone) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 205637 Biodelivery Sciences International Inc. 06/06/2014
Zubsolv (buprenorphine and naloxone) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 204242 Orexo US, Inc 09/04/2013
buprenorphine ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 201760 Sun Pharmaceutical Industries Limited 01/29/2016
buprenorphine ( PI at DailyMed , Info at Drugs@FDA ) ANDA 207276 Rhodes Pharmaceuticals L.P. 03/27/2017
buprenorphine and naloxone ( Info at Drugs@FDA ) ANDA 205022 Kremers Urban Pharmaceuticals Inc 09/19/2016
buprenorphine and naloxone ( Info at Drugs@FDA ) ANDA 201633 Sun Pharm Inds LTD 08/05/2016
buprenorphine hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 090360 Barr Laboratories Inc 02/22/2013
buprenorphine hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 090622 Ethypharm US COR 02/22/2013
buprenorphine hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 090819 Actavis Elizabeth LLC 02/19/2015
buprenorphine hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 201066 Mylan Pharmaceuticals Inc 03/06/2015
buprenorphine hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 078633 Roxane Laboratories, Inc. 02/22/2013
buprenorphine hydrochloride ( Info at Drugs@FDA ) ANDA 090279 Sandoz Inc. 06/10/2015
buprenorphine hydrochloride and naloxone hydrochloride dihydrate ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 203136 Amneal Pharmaceuticals, LLC 02/22/2013
buprenorphine hydrochloride and naloxone hydrochloride dihydrate ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 091422 Actavis Elizabeth LLC 02/22/2013
buprenorphine hydrochloride and naloxone hydrochloride dihydrate ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 204431 Ethypharm USA Corp. 10/16/2015
buprenorphine hydrochloride and naloxone hydrochloride dihydrate ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 091149 Teva Pharmaceuticals USA 09/09/2014
buprenorphine hydrochloride and naloxone hydrochloride dihydrate ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 203326 Roxane Laboratories, Inc. 06/27/2014

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

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Health Care Providers who prescribe or dispense buprenorphine transmucosal products for opioid dependence (BTOD) must

Before treatment initiation (first dose)
  • Assess the patient’s condition to verify the patient meets the diagnostic criteria for opioid dependence.
  • Counsel the patient on the risks described in the professional information and Medication Guide and safe storage of the medication.
  • Complete the Appropriate Use Checklist. Retain a completed copy in the patient’s record or by using another method (e.g. electronic health record) specific to the prescriber’s office practice.
During treatment; at the first visit following induction
  • Prescribe a limited amount of medication.
During treatment; at a return visit scheduled at intervals commensurate with patient stability
  • Assess the patient’s compliance with the prescribed medication, appropriateness of the dosage prescribed, whether patient is receiving the necessary psychosocial support, and whether patient is making adequate progress towards treatment goals.
  • Complete the Appropriate Use Checklist. Retain a completed copy in the patient’s record or by using another method (e.g. electronic health record) specific to the prescriber’s office practice.

Patients who are prescribed buprenorphine transmucosal for opioid dependence (BTOD) products

Before the first prescription
  • Receive counseling from the prescriber on the risks and safe storage of the medication.
During treatment; at a time interval determined by your prescriber
  • Be monitored for compliance with the prescribed medication, appropriateness of the dosage prescribed, assessment of whether receiving the necessary psychosocial support, and whether making adequate progress towards treatment goals.

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers:


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Material Name
Appropriate Use Checklist (PDF)
BTOD REMS Website screenshot (PDF)
Dear Pharmacist Letter (PDF)
Dear Prescriber Letter (PDF)
Pharmacist Brochure, “Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists” (PDF)
Prescriber Brochure, “Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers” (PDF)
REMS document (PDF)
REMS full (PDF)

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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