Opioid antagonist naloxone considered safe for over-the-counter use

The US FDA have approved the distribution of naloxone, a drug that reverses opioid overdose, in an over-the-counter setting, in some dosage forms. 

In some states across the US opioid overdose is the leading cause of death in adults ages 18–44 years. 

Naloxone, an opioid antagonist, is used to reverse opioid overdose. It works by attaching to opioid receptors and blocking other opioids, reversing the effects. 

It can be administered as a nasal spray or injected into the muscle, skin or veins, and is effective in reversing opioid overdoses in all dosage forms. 

The US FDA have now confirmed that naloxone is safe and effective for over-the-counter use, in certain approved forms of administration. 

The regulations cover a dose of up to 4 mg of a naloxone nasal spray and a dose of 2 mg via an auto injector, after initial assessments. 

The FDA is still gathering data on individual products from various manufacturers to establish whether they can also be available for over-the-counter use. They have yet to see whether these products, which supply the drug in different forms, will be considered safe in this setting, as well as examining higher dosage forms. 

Currently, doctors can prescribe naloxone as a life-saving antidote to opioid overdose, if administered quickly to patients prescribed high-dose opioids. Some states in the US allow the use of the drug without prescription, or through official community programmes. 

In 2020, over 16,000 people died from overdoses involving just prescription opioids, this figure has increased year on year. 

By making the opioid antagonist more accessible to at-risk patients, the number of deaths due to overdose will hopefully start to decrease.