Based on feedback from health care practitioners, patients, and professional societies, the FDA issued the Federal Register notice, Modifications to Labeling of Buprenorphine-Containing Transmucosal Products for the Treatment of Opioid Dependence. The encouraged modifications aim to clear confusion around labeling statements for buprenorphine-containing transmucosal products for the treatment of opioid dependence (BTODs).
Feedback indicated a misperception that BTODs labeling specifies a maximum daily dose when, in fact, it does not. For this reason, FDA is recommending revisions to BTOD labeling to avoid misinterpretation of dosing information.
This follows several prior FDA actions regarding buprenorphine and treatment for Opioid Use Disorder (OUD), including the May 2023 issuing of a joint letter with Substance Abuse and Mental Health Services (SAMHSA):
- Clarify the importance of – but not requirement of – counseling and other services as part of a comprehensive treatment plan when providing buprenorphine
- Approve a new buprenorphine treatment option for OUD
- Launch a campaign to inform, encourage, and provide resources to prescribers utilizing medication to treat OUD in May 2024.
Together, these actions aid in propelling the FDA Overdose Prevention Framework, which outlines the FDA’s vision to undertake impactful, creative actions to encourage harm reduction and innovation in reducing controlled substance-related overdoses and deaths.
MyMatrixx Response
MyMatrixx transaction records indicate that scripts for Transmucosal Buprenorphine Products in 2024 were low for our book of business. Our proactive, pharmacy management platform integrates analytics with clinical oversight to monitor and manage the utilization of these medications for the appropriate care and safety of injured workers. If you have questions about the above FDA action or our clinical program, please contact your MyMatrixx account team.