FDA’s Push To Reclassify The Opioid Reversal Agent Naloxone As An OTC Product Needs To Show More Urgency

On November 15th, the Food and Drug Administration (FDA) issued a notice in the Federal Register with respect to the agency’s “preliminary assessment” that “certain naloxone products have the potential to be safe and effective for over‐​the‐​counter use.” The naloxone drug products referenced include dosages of up to 4mg nasal spray and up to 2mg autoinjector for intramuscular or subcutaneous use.

This preliminary assessment is intended to facilitate development and approval of non-prescription naloxone products, including switches from prescription-only to over-the-counter (OTC) status.

But, the FDA’s notice does not include language that would indicate a possible timeline for the agency to initiate a switch on its own if sponsors of naloxone products continue to balk at taking steps towards reclassifying their prescription drugs.

The FDA’s push to reclassify naloxone as an OTC product appears tepid and plodding. At a time when the nation is enduring a severe public health emergency – with record numbers of opioid overdose-related deaths (illicit fentanyl is the primary culprit) – it’s crucial that naloxone become available OTC as soon as possible.

The opioid overdose antidote naloxone was first approved for use in 1971. It is a vital tool used to save lives. It’s clear that naloxone already meets FDA criteria for making the transition to being 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 low misuse potential, and label instructions are understandable by a layperson.

Furthermore, the drug has been available OTC in Italy for more than 20 years, and in Australia for the past seven years.

Moreover, all 50 states have come up with ways to work around the prescription‐​only status of the drug. So, there is an abundance of real-world data on naloxone’s usage as a non-prescription product.

While naloxone can be purchased by certain persons or entities without a prescription in all 50 states, it is not officially an OTC product. The ability to buy naloxone OTC doesn’t apply, for example, to organizations which purchase naloxone in bulk from drug makers.

Without its official designation as an OTC product, there are numerous 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.

A nation-wide switch authorized by the FDA would likely improve access to naloxone, as all pharmacies would have the OTC product. Additionally, it has been suggested that OTC availability throughout the country and at all pharmacies could lead to a substantial decrease in naloxone’s price.

Ultimately, however, if the FDA follows the traditional prescription-to-OTC route – which today’s statement indicates it will – whether naloxone will be switched in the near future will depend on sponsors’ readiness and willingness to submit switch applications to FDA. And that could turn out to be a very long wait. At this point in time, manufacturers of naloxone products have little incentive to submit such OTC petitions. Switched products tend to have lower prices and therefore reduced profits for drug makers.

The FDA says that it is currently identifying ways to assist naloxone manufacturers in submitting an application to the FDA for an OTC version. Specifically, the agency is helping to develop an appropriate package label.

Well, to a large extent that was already happening more than four years ago when I wrote about reclassifying naloxone. In fact, the FDA has repeatedly encouraged naloxone manufacturers to submit prescription-to-OTC switch requests. The agency has exhorted companies to include in their applications evidence from a range of data sources, including label comprehension and actual use studies.

The question becomes, does the FDA have to wait for drug manufacturers to submit applications? The answer is no. Under existing FDA regulations, the FDA can undertake a reclassification review at the request of “any interested person” or the Commissioner himself.

Given the worsening (illicit) opioid overdose crisis, it behooves the FDA to show requisite urgency and force an expedited switch review. Lives are at stake.