Just a week or so ago, there was a significant concern raised regarding the use of buprenorphine in chronic opioid use disorder (OUD) and the development of severe dental caries that occurred in a number of patients who previously had no history of increased caries prior to the start of therapy for OUD (see here). This will likely result in significant labeling changes regarding the use of the film and sublingual dosage forms of buprenorphine.
In pre-publication of a Federal Register notice on December 26, 2024 (here) another labeling change regarding confusion in the maximum single or daily dose in the current “FDA-approved labeling for buprenorphine-containing transmucosal products for the treatment of opioid dependence (BTODs)” should be anticipated.
The change is predicated on what the FDA says is “[T]he reported reluctance of some healthcare practitioners to prescribe buprenorphine daily dosages of 24 mg or higher, and even 16 mg in some instances, may be based on a misinterpretation of the labeling that 16 mg or 24 mg once daily dosages are a required “dosage limit.”
The FR notice above describes the issue in greater detail but look for another labeling change on the horizon in the not-too-distant future once innovators gain approval for dosing changes to help clarify the issue that has confused prescribers. Generics will be required to step in line with those changes for the approved reference listed cited in their approved ANDAs.
