THE US Food and Drug Administration (FDA) has issued a statement of formal support for the development of over-the-counter naloxone to help reduce opioid deaths.
FDA Commissioner Scott Gottlieb said, "With the number of overdose deaths involving prescription and illicit opioids more than doubling over the last seven years to nearly 48,000 in 2017, it's critical that we continue to address this tragedy from all fronts.
"This includes new ways to increase availability of naloxone, a drug used to treat opioid overdose."
In an FDA first, the regulatory body developed a model for the consumer-friendly Drug Facts Label (DFL), a critical step in the development of an OTC product, to encourage drug companies to enter the OTC market.
The model DFL comes in two versions, one for use with a nasal spray and one for an auto-injector.
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