Availability Of Over-The-Counter Narcan Could Help As A Tool To Combat The Illicit Fentanyl Crisis, But Affordability Remains An Issue

Earlier this week, the Food and Drug Administration (FDA) approved the switch of the nasal spray Narcan (naloxone, 4mg) to over-the-counter (OTC) status. Naloxone is used as emergency treatment for opioid overdoses. The FDA made the decision after fast-tracking a prescription to OTC switch application from Emergent BioSolutions, the maker of the branded product.

Narcan nasal spray is the first naloxone product to formally be available without a prescription. While it may take months before Narcan becomes available OTC – and once in pharmacies as an off-the-shelf product its price could keep it out of reach for many – this still represents an important regulatory action.

At a time when the nation is enduring a severe public health emergency, with record numbers of opioid overdose-related deaths – illicit fentanyl being the primary culprit – it’s crucial that tools such as the opioid antidote naloxone become as widely available as possible.

In February, when the FDA advisory panel convened to discuss OTC availability of Narcan, it concluded that making the product available OTC would save lives.

Experts say naloxone is a safe, effective, easy-to-use medicine that works if administered within the first few minutes of an overdose, with little or no potential for abuse. The medication works by binding to the same receptors in the brain as opioids, countering their effects.

The emerging evidence suggests how vital naloxone can be in reducing fatalities due to opioid overdoses. In a 2020 study, 18% of opioid treatment program patients whho were provided naloxone reported having used it at least once to reverse an overdose. Moreover, increased access to naloxone among law enforcement and other first responders has also been found to reduce opioid overdose mortality.

The opioid overdose antidote naloxone was first approved for use in 1971. For years, it’s been clear that naloxone already met the FDA criteria for making a transition from being prescription-only to an over-the-counter product. Naloxone treats a condition that can be identified or self-diagnosed without a medical professional’s guidance, it has a very low misuse potential, and label instructions are understandable to a layperson.

For several years, different formulations of naloxone have been readily available, with no prescription required, thanks to workarounds that include standing prescription orders made by public health officials in every state. This has put the antidote into the hands of more first responders and community distributors.

But regulatory hurdles have made the therapeutic difficult to obtain to ordinary citizens; for example, restrictions are in place that only allow licensed physicians to distribute naloxone. This creates challenges not only for individuals who want access, but also small organizations, like harm-reduction groups that buy the medication in bulk for community distribution. This is exactly where OTC naloxone could make a big difference.

Without its official designation as an OTC product, however, there have been gaps in naloxone availability. To illustrate, naloxone has often been found to be inadequately stocked precisely where it’s needed most; socioeconomically depressed areas with high overdose rates.

And now, as a result of the FDA’s decision, Narcan nasal spray could soon be available OTC in all pharmacies.

Last autumn, I argued that the FDA should show more urgency and make naloxone available OTC as soon as possible, but that affordability could remain an issue. Despite the Narcan switch to OTC, the affordability aspect hasn’t been addressed. Other formulations and dosages of naloxone will remain prescription-only. And so there will be no OTC competitors, effectively giving Emergent BioSolutions a monopoly. The retail price could be as high as $70, which would put it out of reach for precisely the folks that need access to it most. Emergent BioSolutions CEO Bob Kramer has said that his goal is to get the therapeutic into more hands so that people have it when they need it. It’s unclear, however, whether this would include giving certain discounts to low-income individuals.

Making Narcan more widely available is an important step in tackling the opioid overdose crisis, public health experts say, but the price will partly determine how many people can actually benefit from it. If more versions of naloxone are available, that is, competition in the OTC category, this may lead to a substantial decrease in the price.

Just having an OTC product won’t solve the problem of getting naloxone to under-resourced folks, where the risk of overdose is highest. Advocates therefore hope that this FDA approval for OTC Narcan will open the door for regulatory switches of more generic alternatives of naloxone, which would induce competition and drive the price down. In this regard, it’s encouraging news that the FDA has fast-tracked its OTC approval review for another naloxone nasal spray, an inexpensive formulation from the nonprofit Harm Reduction Therapeutics.