FDA panel backs allowing over-the-counter sale of a naloxone spray

A naloxone nasal spray should be sold over the counter, a panel of outside advisers to the Food and Drug Administration ruled unanimously on Wednesday, paving the way for the regulator to expand access to reverse drug overdoses.

The spray works by temporarily reversing the effect opioids, from prescription painkillers to heroin to fentanyl. When given soon after an overdose, it can prevent brain damage and death until paramedics arrive.

The vote follows a day-long joint meeting of two FDA advisory committees to consider a request by Emergent BioSolutions, the maker of Narcan, to sell the product over the counter.

Approving nonprescription use of naloxone could allow the spray to be distributed anywhere from vending machines to big-box stores, the FDA said. Online orders could also be an option, the company told the panel.

“For the seven years that we have marketed this product, we have known that this product is very easy to use. It is used by a variety of community groups, including lay people. It is a four milligram single dose that is safe and effective.” Manish Vyas of Emergent BioSolutions told the committees.

Emergent said in a statement it was “premature to discuss details of how much his drug-device combination would cost.” The over-the-counter version could be available as early as this summer, the company says, once production ramps up after approval.

The cost of naloxone can average up to $250 for uninsured Americans, although insurance companies and other nonprofit or community government programs often offer subsidized or free options. The company said it is working with retailers and government officials on plans for distribution.

Another over-the-counter request for naloxone from the non-profit organization Harm Reduction Therapeutics for their RiVive product is also scheduled to come before the committee next month.

Naloxone has been available for so-called “community” distribution to reverse overdoses since 2016, allowing many to administer the potentially life-saving spray just before attempting to call 911.

Most states have standing orders or similar measures that allow pharmacies and other organizations to dispense naloxone without patient-specific prescriptions, as well as “Good Samaritan” laws to protect bystanders who intervene in overdoses.

But health officials and outside groups say many Americans still face barriers to getting naloxone.

“We have heard from stakeholders, including harm reduction groups, that some pharmacies are reluctant to carry naloxone or find standing orders onerous,” said Dr. Jody Green from the FDA to the committee.

The FDA announced in 2019 it would take another “unprecedented” step toward developing its own labeling — first steps typically left to drugmakers — in hopes of encouraging manufacturers to continue over-the-counter sales of naloxone.

“Additionally, for some opioid users, the stigma of opioid addiction may prevent purchases that require interaction with a pharmacist. We believe over-the-counter naloxone can help overcome these barriers,” Green said.

Emergent has updated the FDA’s model designation for Narcan. The company conducted its own validation study to simulate people using the spray while following its directions.

However, FDA officials told the panel that they found a handful of flaws in the company’s study. And despite limitations that may have skewed the study into positive results, the regulator found there were still flaws in using the spray. Some users started with the wrong steps or administered the spray incorrectly.

The FDA and Emergent said they are still in talks about the final label, which has yet to be resolved along with other issues — such as manufacturing.

Advisors wrestled Wednesday over a handful of discussion questions about tweaks that could reduce the risk of error, including the lack of research into how easily children can navigate the directions.

“The lack of specific studies to help really refine how to make the instructions readable for them is a mistake on our part in trying to develop things,” said committee member Dr. Leslie Walker Harding.

“I don’t think we have to wait for that because every day that we wait there are more people who are going to die,” she added.

The regulator is expected to make its final decision on Narcan by March 29th.

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