“The U.S. Food and Drug Administration announced today the latest action to encourage and support the development of treatment options for people with opioid use disorder (OUD). The agency has released the first of two new draft guidances intended to aid industry in developing new medications for use in medication-assisted treatment (MAT) for opioid dependence. The first guidance, released today, explains the FDA’s current thinking about drug development and clinical trial design issues relevant to the study of sustained-release “depot” buprenorphine products (i.e., modified-release products for injection or implantation).
The FDA’s draft guidance, “Opioid Dependence: Developing Buprenorphine Depot Products for Treatment,” focuses on ways drug companies can more efficiently explore innovations in depot buprenorphine products. A proposed depot buprenorphine product that is similar to an approved product, including in exposure levels to the drug, may have characteristics (e.g., delivery system or formulation) that make it ineligible to be a generic drug approved under an abbreviated new drug application. This draft guidance clarifies that such a product can be submitted in an application under the pathway described in section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, which can provide a more streamlined development pathway.”
Source: FDA.gov – April 20, 2018