FDA Could Soon Approve Over-The-Counter Spray That Prevents Drug Overdose

Reports have emerged that the US Food and Drug Administration (FDA) is fast-tracking the approval process of an over-the-counter (OTC) nasal spray that could help prevent fatal drug overdoses. 

Scheduled to hit the shelves early next year, the naloxone spray has been developed by Emergent BioSolutions, the original creators of Narcan. 

According to Gizmodo, naloxone works by entering the body as an opioid antagonist, preventing other opioids from activating receptors in our cells. As such, the drug can quickly reverse potential overdoses via injections or nasal sprays. 

Thankfully, in the last few months, scientists declared the “affordable naloxone shortage” over, though many experts are still calling for an OTC solution that could be instrumental in reducing the number of opioid deaths. 

As per the Centers for Disease Control and Prevention, over 100,000 Americans died from drug overdoses in 2021, a staggering increase of nearly 15% from the 93,655 fatalities recorded in 2020. 

While the FDA has understandably been reluctant to allow injectable versions of naloxone to be sold, it seems to be considering bringing auto-injectable or nasal sprays to market, even calling for formal applications last month. 

Emergent answered the call, and things are moving fast. The company announced that the authorities have agreed to put its OTC version of Narcan under a priority review, which might be the first time such a review has occurred. 

Could we soon see OTC naloxone sprays selling at local pharmacies? Looks like it may become a reality more quickly than expected. 

“As a leader in the fight to help combat the opioid epidemic, Emergent is committed to increasing access and awareness of naloxone, and we are taking this step to help address the rising and devastating number of opioid overdoses and fatalities happening across the country,” summed up Robert G Kramer, CEO of Emergent.

[via Gizmodo and Emergent BioSolutions / GlobeNewswire, cover image via Borusikk | Dreamstime.com]