FDA moves to fast-track OTC naloxone

The FDA is working to increase access and lower the cost of the lifesaving opioid overdose antidote naloxone by making it easier for drugmakers to produce over-the-counter versions of the medication.

In a Jan. 17 statement, the agency said it has created consumer-friendly labels for the antidote that drugmakers can use when they apply for permission to sell the drug as an OTC nasal spray or autoinjector. The move is to encourage drugmakers to enter the OTC market.

FDA Commissioner Scott Gottlieb, MD, said this is the first time the agency proactively developed and tested a drug facts label for an OTC product.

"FDA-approved versions of naloxone currently require a prescription, which may be a barrier for people who aren’t under the care of a physician or may be ashamed or even fearful of admitting to issues with substance abuse," Dr. Gottlieb said. "Having naloxone widely available, for example as an approved OTC product, is an important public health advance."

Kaleo, naloxone's maker, has a treatment called Evzio with a list price of $4,100. Kaleo launched a generic version with a price of $178 in December last year. The price includes two auto injectors per carton.

Another naloxone product, Narcan, which retails for $125, has a generic version that costs $40. The FDA is working to lower that cost more and increase consumer access by selling the drug over the counter.

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