The FDA is considered relaxing laws for naloxone sprays

According to the latest figures from the US Centers for Disease Control and Prevention, there were over 107,000 deaths due to drug overdoses in the US last year. Furthermore, fentanyl and other synthetic opioids were involved in more than two-thirds of all those deaths. 

Despite opioid use declining in general in the last few years, there were still more than 142 million opioid prescriptions in the US last year, with 43 for every 100 people. 

Due to these high figures, FDA advisers have announced that they are considering making a nasal spray version of an opioid overdose antidote available over the counter. 

The nasal spray Narcan, a brand name of naloxone,  is a medication used to reverse or reduce the effects of opioids, especially decreased breathing that occurs after an overdose. 

A company called Emergent BioSolutions Inc. submitted an application to the FDA last year for a generic lifesaving naloxone spray, and this was granted a priority review by the agency. 

Naloxone was approved by the FDA in 1971 and was initially used by emergency services in hospitals for resuscitation purposes. Research shows that wider access to the medication, which comes in several dosages and application types, could save thousands of lives. 

The application will be put forward to the FDA’s Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee, and if approved, it could be available later in the year over the counter. 

However, there are still some concerns, like the labelling and ease of use for those without medical training. The briefing documents insist that the nasal spray is designed for people without medical training and it’s easier to use than injections. 

Some experts believe allowing naloxone to be sold over the counter would make it more accessible, due to the stigma around asking for it. All US states have allowances that allow it to be sold in pharmacies, but many pharmacies don’t sell it due to issues around prescriptions. This change would remove the legal confusion and potentially reduce overdose deaths.