FDA moves to advance the development of new products for opioid use disorder

In the wake f the ongoing opioid crisis in the USA, the  Food and Drug Administration on Friday announced 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 medicines for use in medication-assisted treatment (MAT) for opioid dependence. The first guidance explains the FDA’s current thinking about drug development and clinical trial design issues relevant to the study of sustained-release “depot” buprenorphine products (ie, modified-release products for injection or implantation).

“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. “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,” he added.