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Opioid Treatments Could Get Survival Claim As US FDA Develops Protocol

 
• By Brenda Sandburg

Commissioner Gottlieb announces several actions in the works to promote development of new treatments for opioid addiction, including guidance on how to establish novel endpoints.

The US FDA is upping its efforts to facilitate the development of new medications for the treatment of opioid use disorder. FDA Commissioner Scott Gottlieb announced that the agency is developing a protocol intended to support a claim that the availability of medication-assisted treatment (MAT) when a patient presents with overdose could lead to reduction in death over a population.

"Such an effort would be a first for the FDA," Gottlieb said in a Nov. 30 statement.

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