FDA has issued the Federal Register notice, Modifications to Labeling of Buprenorphine-Containing Transmucosal Products for the Treatment of Opioid Dependence, to encourage the submission of supplemental new drug applications to modify the labeling statements for buprenorphine-containing transmucosal products for the treatment of opioid dependence (BTODs).
FDA has received feedback from multiple interested parties (e.g., health care practitioners, patients, professional societies), indicating a misperception by some that labeling for BTODs includes a maximum daily dose when, in fact, the labeling does not specify a maximum dose. We also received similar feedback through several meetings in which FDA participated, including a two-day public meeting with the Reagan-Udall Foundation for the FDA in May 2023 and two listening sessions led by the Substance Abuse and Mental Health Services Administration (SAMHSA) in November and December 2023. For this reason, FDA is recommending revisions to BTOD labeling to avoid misinterpretation of dosing information.
Today’s action follows several prior FDA actions regarding buprenorphine and treatment for OUD, including issuing a joint letter with SAMHSA in May 2023 to clarify the importance of counseling and other services as part of a comprehensive treatment plan, as well as reiterating that providing buprenorphine should not be made contingent upon participation in such services; approving a new buprenorphine treatment option for OUD in May 2023; and launching a campaign to inform, encourage, and provide resources to prescribers utilizing medication to treat OUD in May 2024.
Together, these actions aid in propelling FDA forward in implementing the FDA Overdose Prevention Framework, which provides our vision to undertake impactful, creative actions to encourage harm reduction and innovation in reducing controlled substance-related overdoses and deaths. As we continue executing that vision, we remain focused on responding to all facets of substance use, misuse, overdose, and death through the four priorities of the framework, including: supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction through innovation and education; advancing development of evidence-based treatments for substance use disorders; and protecting the public from unapproved, diverted, or counterfeit drugs presenting overdose risks.
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