Inside The Push For Over-The-Counter Naloxone

By Keri Blakinger 01/22/19

The FDA has recently taken an unprecedented step to kickstart the development of over-the-counter naloxone products. 

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naloxone vials

Last week the FDA took an unprecedented step to make the anti-overdose drug naloxone directly available to opioid users.

Currently, naloxone requires a prescription. But in an effort to make approval for non-prescription versions of the drug easier for pharmaceutical companies to get, the FDA developed sample labels that would meet federal Drug-Facts Label requirements for over-the-counter products. It marks the first time the drug agency has ever proactively created labelling to expedite the process.

“Naloxone is a critical drug to help reduce opioid overdose deaths. Prevention and treatment of opioid overdose is an urgent priority,” the agency wrote in an unsigned statement. “Increased availability of naloxone for emergency treatment of overdoses is an important step.”

The agency created two model labels, one for a nasal spray version of the drug and one for an auto-injector version. Both versions include a short information box about the drug and its uses, followed by an illustrated guide on how to administer the life-saving treatment and a warning about the drug’s expected effects.

“These efforts should jumpstart the development of OTC naloxone products to promote wider access to this medicine,” the FDA wrote. The agency tested the labeling through a research contractor to verify that potential users could understand the images and warnings.

“This work builds on our ongoing efforts to get this life-saving drug into the hands of those who need it most,” the statement continued. “In addition to the approval of injectable naloxone for use in a health care setting and both prescription auto-injector and intranasal forms of naloxone, which facilitate use by laypersons, we also released draft guidance to advance development of generic naloxone hydrochloride nasal spray.”

The move comes amid a long-term rise in overdose deaths, as close to 48,000 people died from opioids in 2017 – double what the figure was seven years earlier, according to the federal agency. Overdoses can cause drug users to lose consciousness and stop breathing, but naloxone reverses those effects if given quickly enough. 

Though the injectable version is pricier, a two-pack of the brand-name nasal spray version sells for about $125, according to CNBC. The generic is around $40 per dose. In theory, offering up a label that could make over-the-counter access easier might help lower those figures further by eliminating the need for would-be buyers to spend money on seeing a doctor for a prescription.

“While the person administering naloxone should also seek immediate medical attention for the patient,” the agency said, “the bottom line is that wider availability of naloxone and quick action to administer it can save lives.”

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Keri Blakinger is a former drug user and current reporter living in Texas. She covers breaking news for the Houston Chronicle and previously worked for the New York Daily News and the Ithaca Times. She has written about drugs and criminal justice for the Washington Post, Salon, Quartz and more. She loves dogs and is not impressed by rodeo food. Find Keri on LinkedIn and Twitter.

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