FDA speeds tracking of over-the-counter naloxone, which could reduce overdose deaths

In the spring, a drug used to reverse opioid overdoses might be available at your local pharmacy without a prescription.

Last week, Emergent BioSolutions Inc. announcement that the US Food and Drug Administration (FDA) was fast-tracking approval for over-the-counter sales of Narcan, a naloxone nasal spray, which can quickly treat and reverse an opioid overdose before it kills.

In November, the FDA issued an assessment that some naloxone nasal sprays may be safe to use without a prescription without the help of a healthcare professional. The agency is currently collecting additional data and taking comments through January before making a final decision, but FDA Commissioner Robert Califf has a positive view of the outcome.

“[November’s] The action supports our efforts to address the opioid overdose crisis by helping to expand access to naloxone,” he said at the time. “The agency will maintain overdose prevention and reduction of substance use disorders as a key priority and an area for intense strategic action as quickly as possible.”

The deadline for approval, according to a statement from Emergent BioSolutions, is March 29, 2023. If accomplished, it would be a wonderful and long-awaited development in efforts to curb opioid overdoses. Deaths from opioid overdoses in America reached a record of over 71,000 in 2021. Total number of overdose deaths exceeded 100,000 This year. Easier access to drugs that can prevent these deaths is something the government should allow as part of its harm reduction strategy.

Filtered magazine notes that in September, the FDA took steps to exempt naloxone from certain federal distribution restrictions. The federal government declared a public health emergency in 2017 due to opioid addiction and overdoses, and as such, the FDA wanted to reduce barriers to wholesale access to naloxone. Alliance Remedy, a naloxone buyers’ club, works to make the drug more accessible by making mass bulk purchases that members then distribute in communities. The FDA’s September decision allows suppliers to buy naloxone in bulk without risking violating federal drug supply chain regulations.

Allowing people to simply take Narcan from a pharmacy without a prescription would provide even greater access and be a boon for anyone who knows someone at risk of an overdose. We don’t yet know what the over-the-counter price might be, but GoodRx lists the average prescription retail price at $89.70 for a box of two naloxone nasal sprays. Some are under $40 with special offers.

At this time, it appears that Emergent BioSolutions’ product may be the first to hit the market, but it is likely to soon face competition from other naloxone suppliers, which will help drive prices down. Maybe the market will provide a solution that our the misguided war on drugs clearly did notassuming the FDA steps aside and allows this to happen.