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).
Use of MAT for opioid dependence relies on prescription drugs, including buprenorphine, methadone and naltrexone, to stabilize brain chemistry; reduce or block the euphoric effects of opioids; relieve physiological cravings; and normalize body functions. Regular adherence to MAT with buprenorphine helps patients gain control over their use of opioids, without causing the cycle of highs and lows, intoxication and withdrawal associated with opioid misuse or abuse. At proper doses, buprenorphine can also block the pleasurable effects of other opioids, making continued opioid abuse less attractive. Passive-compliance formulations (those that do not require taking a daily medication), such as sustained-release depots or implantable devices that release a continuous level of the drug, can provide effective treatment of opioid dependence that may also result in less misuse, abuse or accidental exposure compared to the self-administered formulations such as transmucosal tablets and films, which are absorbed through mucous membranes of the mouth.
The FDA’s draft guidance, “Opioid Dependence: Developing Buprenorphine Depot Products for Treatment,” focuses on ways drug companies can more efficiently explore innovations in depot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 This draft guidance clarifies that such a product can be submitted in an application under the pathway described in section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act,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.
This draft guidance also explains the types of studies the FDA recommends for depot buprenorphine products that are similar to an approved depot product, as well as depot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. For example, the draft guidance provides information on efficacy studies including trial design, recommended efficacy endpoints, and novel efficacy endpoints that can help researchers link exposure levels to the safety and benefit of new, longer-acting formulations of existing drugs.
For more information, please visit: Advancing development of products for treating OUD.