What is the BTOD REMS?

The Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for Buprenorphine-containing Transmucosal products for Opioid Dependence (BTOD). A REMS is a strategy to manage known or potential serious risks associated with a drug product and is required by the FDA to ensure that the benefits of a drug outweigh its risks.

The goal of the BTOD REMS is to inform healthcare professionals and patients about the safe use conditions and serious risks, including accidental overdose, misuse, and abuse, associated with BTODs indicated for the treatment of opioid dependence.

What products are covered under the BTOD REMS?

BTODs are available both as products containing buprenorphine only and products that combine buprenorphine with naloxone; both types of products are indicated for the treatment of opioid dependence.

The following products are covered under the BTOD REMS:

  • Generic equivalents of Subutex® (buprenorphine) sublingual tablets
  • Generic equivalents of Suboxone® (buprenorphine and naloxone) sublingual tablets
  • Suboxone® (buprenorphine and naloxone) sublingual films and generic equivalents
  • Zubsolv® (buprenorphine and naloxone) sublingual tablets
  • Cassipa® (buprenorphine and naloxone) sublingual films

The use of BTODs should be part of a comprehensive treatment plan to include counseling and psychosocial support. 

Where can I obtain additional information?

Please see the Prescribing Information and Medication Guide for all BTODs.

For more information about the BTOD REMS, including all materials and instructions call 1-855-223-3922.

General information about buprenorphine treatment and the treatment of addiction are available through numerous sources, including but not limited to:


Click here for a complete list of products covered under the BTOD REMS

Materials for Prescribers:

Materials for Pharmacists:

Materials for Patients:

For more information or to receive print copies of the materials, please call: