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FDA takes unprecedented step to spur OTC naloxone development
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The FDA has, for the first time, proactively developed and tested a product label to encourage development of an over-the-counter version of the opioid overdose antidote naloxone, according to an agency statement.
The agency’s action removes the burden from the companies of creating such labels and conducting studies that show consumers can use a product without a health care professional’s supervision.
“Some stakeholders have identified the requirement to perform these studies as a barrier to development of OTC naloxone products,” Scott Gottlieb, MD, FDA commissioner, said in the statement. “These efforts should jumpstart the development of OTC naloxone products to promote wider access to this medicine.”
The labels were created for both auto-injector and nasal spray forms of naloxone. They contain all the information needed for such OTC products except for details unique to the individual product that a consumer needs to administer naloxone safely and effectively, Gottlieb said.
AMA, who earlier this year approved several policies to remove opioid treatment barriers, commended the FDA’s move.
“The AMA applauds the FDA and Commissioner Gottlieb,” Patrice A. Harris, MD, AMA president-elect and chair of the AMA Opioid Task Force said in a statement.
“Naloxone has saved tens of thousands of lives, and the AMA continues to strongly urge physicians to co-prescribe naloxone to patients at risk of opioid-related overdose,” she added.
AAFP and ACP voiced support for the Comprehensive Addiction and Recovery Act in 2016. The law included a component which would increase availability of opioid overdose reversal drugs such as naloxone. – by Janel Miller
Disclosures : Gottlieb is FDA commissioner; Harris is AMA president-elect.