“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…”
“The FDA’s draft guidance, “Opioid Dependence: Developing Buprenorphine Depot Products for Treatment,” focuses on ways drug companies can more efficiently explore innovations in depot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…”
“This draft guidance also explains the types of studies the FDA recommends for depot buprenorphine products that are similar to an approved depot product, as well as depot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 For example, the draft guidance provides information on efficacy studies including…” Read the full press release here.
Source: FDA takes new steps to advance the development of innovative products for treating opioid use disorder – April 20, 2018. FDA.gov.
