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The agency has released new guidance on the development of new medication-assisted treatments for opioid dependence.
On April 20, 2018, FDA published draft guidance on the development of new medication-assisted treatments for opioid dependence. This first of two guidance documents is part of the agency’s action to encourage innovation in the development of opioid addiction treatments.
The new draft guidance, Opioid Dependence: Developing Depot Buprenorphine Products for Treatment, discusses drug development and trial design issues relevant to the study of depot buprenorphine products (i.e., modified-release products for injection or implantation), for which submission of a new drug application (NDA) through the pathway described in section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) may be appropriate. In the guidance, the agency addresses development plans, including studies to support approval and efficacy trials.
“Today’s action by FDA reflects the Trump Administration’s commitment to bringing the best science we have to bear in the fight against opioid addiction. 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 press release. “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.”
“These new guidance documents may ultimately lead to new treatments that improve outcomes for those struggling with an opioid addiction … In addition, in the coming months, we will take additional steps, beyond these guidance documents, to help promote the development of better treatments for those suffering from opioid use disorder,” Commissioner Gottlieb said in a statement.