Naloxone HCl Nasal Spray Seeks OTC Status To Reduce Opioid Epidemic

According to the U.S. Centers for Disease Control and Prevention, the ongoing opioid epidemic is a national public health issue exacerbated by the escalating use of synthetic opioids.

To address this epidemic, the U.S. Food and Drug Administration (FDA) accepted Emergent BioSolutions Inc.'s supplemental New Drug Application (sNDA) for NARCAN® (naloxone HCI) Nasal Spray as an over-the-counter (OTC) emergency treatment for known or suspected opioid overdose.

Emergent's sNDA has been granted Priority Review by the FDA and, if approved, would be the first 4 mg naloxone nasal spray available OTC in the U.S. 

The FDA's Prescription Drug User Fee Act goal date is March 29, 2023.

Since its approval in 2015, Emergent has distributed millions of prescription NARCAN devices across the U.S.

Currently, people can purchase NARCAN® directly from their pharmacy without a prescription from their doctor.

"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 a devastating number of opioid overdoses and fatalities happening across the country," said Robert G. Kramer, president and CEO of Emergent BioSolutions, in a related press release on December 6, 2022.

According to the CDC, deaths related to synthetic opioids increased nearly 60% from 2019 to 2020.

And in 2021, about 71,000 people died from opioids containing fentanyl.

Note: NARCAN® Nasal Spray is a prescription medicine used for the treatment of a known or suspected opioid overdose emergency with signs of breathing problems and severe sleepiness or not being able to respond. Please see the full Prescribing Information.