The growing problem of drug overdoses, a significant public health threat in the United States, is one of the drivers for this approval.
Between March 2022 and February 2023, more than 105,000 overdose deaths were reported, with synthetic opioids such as illicit fentanyl as the main cause. Naloxone, capable of rapidly reversing the effects of an excessive dose of opioids, is the standard treatment in such cases.
This is the second over-the-counter naloxone product the agency has approved.
In addition, its safety and efficacy have been verified when used according to the indications provided. The data also demonstrates that users can safely and effectively administer the drug without medical supervision.
Over the past year, the agency has worked to expand opioid disposal options to reduce the chances of non-medical use, accidental exposure, and overdose.
