FDA takes new steps to advance the development of innovative products for treating OUD
FDA announced on Friday the latest action to encourage and support the development of treatment options for individuals with opioid use disorder (OUD).
FDA announced on Friday the latest action to encourage and support the development of treatment options for individuals with opioid use disorder (OUD). The agency released a <a href="https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInforma…; target="_blank">draft guidance</a> aimed at helping industry in developing new medications for use in medication-assisted treatment (MAT) for opioid dependence. The guidance explains FDA's current thinking about drug development and clinical trial design issues relevant to the study of sustained-release "depot" buprenorphine products. "We know medication-assisted treatment is effective in treating addiction, and we at the Department of Health and Human Services are using every avenue we have to boost access to it," said HHS Secretary Alex Azar. "FDA Commissioner Scott Gottlieb has made advancing medication-assisted treatment a priority at FDA in particular, and we believe this new guidance can help accelerate the pathway for developing new drugs and new formulations of existing drugs." The new draft guidance highlights ways drug manufacturers can more efficiently explore innovations in depot buprenorphine products. The agency noted that a proposed depot buprenorphine product that is similar to an approved product, including in exposure levels to the drug, may have characteristics that make it ineligible to be a generic drug approved under an abbreviated new drug application. The guidance also describes the types of studies FDA recommends for depot buprenorphine products that are similar to an approved depot product, as well as depot buprenorphine products with novel features relative to approved depot products.