A new draft guidance document from FDA aims to help pharmaceutical manufacturers develop new medications to treat opioid use disorder (OUD).
The guidance explains the FDA’s current thinking about drug development and clinical trial design issues relevant to sustained-release “depot” buprenorphine products (modified-release products for injection or implantation).
“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, in a statement from FDA. “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.”
“Unfortunately, far too few people who suffer from opioid use disorder are offered an adequate chance for treatment that uses safe and effective medications,” Gottlieb said in the statement. “The FDA will continue to encourage more widespread innovation and development of new and better treatments for opioid addiction as well as tackle the unfortunate stigma that’s sometimes associated with use of these treatments. More widespread adoption of treatment with safe and effective medications, coupled with relevant social, medical and psychological services, has the highest probability of being the most effective way to help those suffering from opioid addiction transition to lives of sobriety.”
The 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 (such as delivery system or formulation) that make it ineligible to be a generic drug approved under an abbreviated new drug application, FDA said.
The draft guidance also explains the types of studies FDA recommends for depot buprenorphine products that are similar to an approved depot product, as well as depot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.
For example, the draft guidance provides information on efficacy studies including trial design, recommended efficacy endpoints, and novel efficacy endpoints that can help researchers link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.