麻豆传媒

"Opioid emergencies can happen anytime, anywhere. Be the difference between life and loss."

This is just you might have seen or heard for over-the-counter (OTC) naloxone (Narcan), the medication used to treat overdoses from drugs like fentanyl. Not only are pharmaceutical companies putting out these advertisements, but government agencies and public health organizations too have been promoting OTC naloxone. Just recently, the White House even announced aiming to promote increased naloxone access to combat overdoses.

For anyone following our "opioid epidemic," efforts to increase naloxone availability and access by any means. However, such efforts from the federal government have been much more recent. In fact, one of the biggest developments on this front came just over a year ago in March when the FDA approved the first naloxone product to be sold OTC, without a prescription. In July, a second product, RiVive intranasal naloxone, .

While these efforts have been rightfully lauded as much-needed progress, there is a concern that naloxone is as it needs to be and that little has really changed in over a year since OTC approval.

The State of the Opioid Crisis

For starters, drug overdose deaths in the U.S. broke another grim record in 2023, with more than lost in just 12 months. This record was again driven primarily by fentanyl, which accounted for of this tragic sum. While fentanyl has received significant attention in recent years, misinformation abounds, so it is important to clarify that fentanyl is an old, well-studied and well-understood opioid drug, and that we have a nearly perfect antidote -- -- for fentanyl overdose. The antidote has been subject to much misinformation itself.

Understanding the Full Picture

But the overdose statistics alone don't necessarily tell the full story. The effects of broad policy changes (like the move to OTC naloxone) on population-level statistics (like national overdose mortality) can lag and often are not apparent within months or even a year. For example, buprenorphine, a medication to treat opioid use disorder, has seen similar lags in uptake since restrictions on prescribing were removed last year.

While to treat every opioid overdose, and could theoretically prevent every opioid overdose death, naloxone is not going to do anything to prevent overdoses or treat opioid use disorder. Additionally, the prevalence of xylazine, a non-opioid drug that does not respond to naloxone, seems to be increasing, although still mostly in conjunction with fentanyl.

There are also other, more immediate causes for concern when it comes to naloxone.

A Troubled Rollout

Several issues have plagued the wider distribution of OTC naloxone: a slow-moving rollout, high costs, and volume concerns, among others.

After its approval, the first OTC product didn't actually hit store shelves until September 2023. This followed decades of other setbacks. Naloxone itself has been FDA-approved since 1971, and has been OTC in other for years now.

Furthermore, Emergent BioSolutions, the manufacturer of the March-approved OTC naloxone product, has been accused of -- the drugmaker was reportedly reluctant to submit an application for OTC status until a competitor had prepared such a bid (and more broadly, the company has been accused of using legal tactics to delay generic competition). Notably, the injectable formulation has been available in generic formulation for many years, yet it is not available OTC in the U.S. despite being , as effective () than intranasal formulations, and still very easy to use.

Cost is another barrier to access. Emergent BioSolutions reduced the price to $45 for two, one-time-use intranasal spray devices, compared to $130 for the prescription version of the same product. The July-approved OTC product, from Harm Reduction Therapeutics, first shipped to stores in December 2023 and was priced at $36 for a 2-pack.

While these represent significant price reductions, many still have concerns about , especially considering that many insurers cover the cost of prescription naloxone and may not cover an OTC product. Also, since public health and other organizations often distribute the prescription version for free after securing manufacturer discounts, people may be hesitant to buy their own, and then wind up without the drug in a moment of crisis.

Literal access is another issue: multiple, that these products are hard to find in . While many have reported seeing the OTC product available in major chain pharmacies, it still does not seem to be widely available in places like supermarkets, other big box chains, convenience stores, corner markets, and gas stations.

Broadening the locations where it's available matters. Even the prescription-only naloxone products -- behind the pharmacy counter -- became obtainable without an individual prescription after standing orders allowed pharmacists to dispense it to anyone who asked for it. These laws were instituted in most (47) states in response to the opioid crisis. These pharmacy standing orders still faced surrounding , which was part of the impetus for an OTC product. Yet, it seems that OTC Narcan is facing many of the , namely that it is mostly still only found in pharmacies -- sometimes still behind the counter or in locked cases -- if they have it at all.

The Need for Expanded Access

The greatest potential for this lifesaving medicine will only be achieved if it is truly accessible to everyone.

While newer, higher-dose and higher-potency prescription products have come to market in recent years, there is no significant evidence at this point to say that these products are . Furthermore, they are prescription-only and significantly more expensive.

Amid , it is important to note that experts replacing naloxone with these products. Continuing to to naloxone, including the cheaper injectable administration kits, is that still need work when it comes to addressing our drug crisis. For example, the to manufacture and sell a generic version of the drug is encouraging. We need more like it.

Every opioid overdose could potentially be stopped by timely administration of naloxone. Hopefully OTC naloxone will continue to encourage more people to commit to saving lives by knowing where naloxone is and how to use it, and reducing stigma around this truly lifesaving medicine. I can say firsthand that there is no greater regret than not being able to save a life from an overdose and knowing you could have.

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