The controversy around higher-dose naloxone formulations to combat fentanyl overdose
Pharmaceutical companies have introduced a variety of new naloxone products, including a mechanized injector, prefilled syringe pen, high-dose nasal spray, and autoinjector. These higher-dose formulations have been marketed aggressively amid heightened fears surrounding fentanyl. Fentanyl’s presence in the U.S. drug supply has sent overdose rates soaring.
However, highly misleading, fear-driven narratives have been spread about fentanyl, such as “rainbow fentanyl” targeted at children and claims of overdosing by touching it. Advocates say that the standard 4-milligram dose of intranasal naloxone continues to effectively reverse overdoses. Several academic studies have found no significant difference in the doses of naloxone used to reverse overdose in patients who had and had not consumed fentanyl.
Additionally, unnecessarily large naloxone doses can cause debilitating withdrawal symptoms in overdose victims soon after they regain consciousness, which can lead to a repeat overdose. The behavior of drug companies mirrors a practice of protecting profit margins by continually offering medications in new formulations and delivery mechanisms. Naloxone-access advocates criticize organizations for buying expensive products instead of cheaper generic naloxone, representing a dangerous diversion of resources.
Narcan nasal spray approved for over-the-counter use in the US
The FDA has approved Narcan nasal spray for over-the-counter (OTC) use in the US. This marks the first time that any naloxone product has been approved for use without a prescription. The FDA’s approval paves the way for the lifesaving medication to be sold directly to consumers in places like drug stores, convenience stores, grocery stores, gas stations, as well as online.
Other formulations and dosages of naloxone will remain available by prescription only. Over 101,750 fatal overdoses occurred in the 12-month period ending in October 2022, primarily driven by synthetic opioids like illicit fentanyl. The FDA’s approval is part of its efforts to combat the overdose crisis in the US.
However, the use of Narcan nasal spray in individuals who are opioid dependent may result in severe opioid withdrawal. The FDA has taken a series of measures to help facilitate access to naloxone products, such as encouraging sponsors to submit applications for approval of OTC naloxone products and designing a model naloxone Drug Facts Label. The FDA remains focused on responding to all facets of substance use, misuse, substance use disorders, overdose, and death in the US through its Overdose Prevention Framework.
The potential dangers of over-the-counter sale of naloxone and its impact on drug addiction
While the approval of OTC Narcan nasal spray represents a significant milestone in combating the opioid epidemic, some experts are concerned about the potential dangers of over-the-counter sale of naloxone and its impact on drug addiction. Addiction scholar Stefan Kertesz believes in educating Boy Scouts about the distribution of naloxone as a potential Eagle Scout project.
The potential over-the-counter sale of naloxone as a nasal spray could normalize self-destructive behavior that leads to overdose deaths. The “harm reduction” movement’s focus on “every life matters” could lead to a dangerous increase in Narcan use. Robert Marbut, a senior fellow at the Discovery Institute, believes that expanding access to Narcan could lead to misuse and overuse, resistance to the drug, minor brain damage, and the normalization of overdoses.
The public’s belief in the “magic medicine” of Narcan has not been sufficiently tested, despite the Biden administration’s advocacy for its use. The story of Kai Adame, a young San Francisco resident who died after stopping breathing 13 times due to drug addiction, highlights the potential benefits and risks of Narcan use.
Experts call for an alignment of public health needs and profit motives. Cheap generic versions of naloxone packaged at reasonable doses are needed, but they are not profitable for companies since naloxone has been off-patent since 1985. High-cost products divert resources away from cheaper forms of naloxone. The fear of fentanyl has allowed companies to push the narrative that standard doses are no longer enough.
Recent examples of questionable new products include Kloxxado, Zimhi, and Evzio selling for far higher prices than generic counterparts. Local health organizations have begun to switch to cheaper generic naloxone. Manufacturers argue that higher doses are safer and increase bioavailability, eliminating the risk of nasal blockages. However, experts caution against this approach, as unnecessarily large naloxone doses can cause debilitating withdrawal symptoms in overdose victims soon after they regain consciousness, which can lead to a repeat overdose.
In conclusion, while expanded access to naloxone is essential in combating the opioid epidemic, pharmaceutical companies must prioritize public health over profits. Experts call for an alignment of public health needs and profit motives to ensure that cheap generic versions of naloxone packaged at reasonable doses are available widely.
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