FDA changes buprenorphine labeling to favor higher doses

In December, the Food and Drug Administration (FDA) 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). BTODs are medications that are dissolved in the mouth and contain buprenorphine, or a combination of buprenorphine and naloxone, and are indicated to treat opioid use disorder (OUD)—previously referred to as opioid dependence.