Two panels advising the Food and Drug Administration voted unanimously on Wednesday to recommend making naloxone, an opioid overdose-reversing drug, available over the counter in nasal-spray form. This would be a crucial step toward making this lifesaving drug more accessible.
The FDA first approved the drug in 1971 in a liquid, injectable form. Emergency physicians, nurses and paramedics routinely administer it to patients overdosing on an opioid. The liquid form comes in a glass vial and requires a needle and syringe to draw up the right amount. If the patient has an intravenous line, the medicine could go into the IV; if not, it is injected into the patient’s muscle.
For decades, harm-reduction advocates have been teaching drug users to inject naloxone. When I first started as Baltimore’s health commissioner, I learned that workers on the city’s needle exchange vans had long been teaching clients to administer naloxone to people who had stopped breathing and would otherwise die.
These workers and their clients were every bit as capable of injecting naloxone into an overdose victim as my colleagues in the emergency department. And because people who use drugs are likely to be around others at risk for overdose, they should have naloxone available to save lives.
Despite the clear benefit, many legislators opposed giving out injection medicines to drug users, citing a misconception that a needle and syringe would be too difficult for ordinary people to use. For a time, my team and I tried an intermediate strategy: Provide an atomizer device that attaches to the syringe and turns the liquid into a mist that can be sprayed into the victim’s nose. Then came nasal Narcan, a brand-name spray naloxone that uses a mechanism similar to popular allergy medicines, which was easier for policymakers to get behind.
Still, the retail price for nasal-spray naloxone remains a substantial barrier. The two companies with applications pending before the FDA for over-the-counter use, Emergent BioSolutions and Harm Reduction Therapeutics, have not yet said how they plan to price their medications. But even with insurance reimbursement, they won’t come close to the much lower cost of injectable naloxone.
Nabarun Dasgupta, an epidemiologist and researcher at the University of North Carolina at Chapel Hill, stresses that the cheaper, injectable version will be essential to community groups and local and state governments purchasing the drug. Dasgupta is intimately familiar with naloxone pricing. In addition to his academic work, he is co-founder and board chair of Remedy Alliance/For the People, a nonprofit that distributes generic, low-cost liquid naloxone to community programs.
Remedy Alliance purchases naloxone directly from manufacturers at a heavily discounted price and then sells it at less than $2 per dose to harm-reduction groups. This is possible because many state and local governments have issued blanket prescriptions allowing naloxone to be distributed. But not all of these standing orders cover the liquid injectable naloxone.
Dasgupta isn’t opposed to disbursing the nasal spray over the counter, but given finite resources, he wants to make sure that the much cheaper version can also be distributed widely. To that end, he thinks standing orders should cover the liquid injectable, and, ideally, the liquid version should have the prescription requirement removed.
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That second part is more difficult. Though there are many years of experience with injectable naloxone, advocates tell me that the FDA is unlikely to grant over-the-counter approval to a medication that requires a needle and syringe.
This is a mistake. As Dasgupta argues, “The harm-reduction community has been using injectable naloxone for decades.” Ignoring its ease of use among laypeople would be a “demeaning erasure of history.”
There are some circumstances in which injectable naloxone is preferable to the nasal spray. For example, Dasgupta told me about a mother who found her son unconscious on the ground from an overdose. His body was lying across a door, and she couldn’t open it enough to reach his nose. Fortunately, she had the liquid formulation and was able to revive him by injecting it into his leg.
“Over-the-counter status for the nasal spray doesn’t replace the need for far more liquid naloxone distribution,” Dasgupta said.
I agree with Dasgupta. Making nasal naloxone available over the counter is a major milestone, but it’s not enough. In addition to increasing access to addiction treatment and other harm-reduction tools such as fentanyl test strips, the liquid injectable should be far easier to get, especially for drug users most likely to overdose and for their loved ones who can save their lives.