The agency on Thursday announced a change to the labeling of naloxone that eventually would allow for over-the-counter use as a nasal spray and as an auto injector. “Naloxone is a critical drug to help reduce opioid overdose deaths” said FDA Commissioner Dr. Scott Gottlieb in a written statement. “Increased availability of naloxone for emergency treatment of overdoses is an important step—one potential way to improve access to naloxone is to make it available for over-the-counter sale.”
Naloxone has been considered a crucial tool in the effort to reduce the number of drug overdose deaths that has skyrocketed in recent years due to the opioid epidemic.
In 2017, nearly 48,000 overdose deaths involved prescription and illicit opioids, well more than half of the more than 72,000 overdose deaths that occurred that year.
Many cities and states have imposed standing orders to expand access to naloxone in recent years to allow anyone to purchase it at a pharmacy, while many first responders including police are equipped with the product.
And a growing number of healthcare providers have instituted policies that call for clinicians to co-prescribe naloxone every time they prescribe opioids.
More than 191 million opioid prescriptions were written in 2017, according to the Centers for Disease Control and Prevention.
The increase in demand for naloxone has led to shortages, which has led to complaints over increases in the price of the drug. A study published in November in the journal Addictive Behaviors found increased demand, drug shortages, and limited competition among drug makers had all contributed to price increases ranging from 244% to 3,797% from 2006 to 2017.