February 9, 2019

FDA Nudges Developers to Create Over-the-Counter Naloxone

The FDA announced an initiative to encourage drug companies to develop over-the-counter (OTC) formulations of naloxone, the opioid overdose reversal agent, in order to improve consumer access to the drug and reduce opioid-related fatalities.

A key step to being granted FDA approval on an OTC drug is the development of a consumer-friendly drug facts label (DFL) alongside studies demonstrating that consumers can understand how to use the product without the supervision of a healthcare professional.

Many have claimed this process to be a barrier to development. To spur OTC development, for the very first time the FDA has proactively developed and tested DFLs for an OTC product, releasing model DFLs for naloxone auto-injectors and nasal sprays.

Going a step further, the FDA also conducted the necessary label comprehension testing, establishing that these DFLs are consumer friendly and essentially clearing a primary hurdle for drug developers, allowing drug makers to insert product-specific information into their labels and focus on product development.

It is very likely that this will lead to the creation of OTC naloxone products, as naloxone has seen a variety of legislative and regulatory actions over the last several years, expanding access to this life-saving drug. In fact, in certain states, select pharmacies sell naloxone without a prescription. However, as an OTC, the utilization of naloxone may go unnoticed in workers’ comp, whereas its mere presence in a claim could serve as a helpful red flag to spot issues with opioid utilization.

For more information, read the FDA’s press announcement.

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