FDA Approves First OTC Naloxone Nasal Spray to Combat Opioid Overdose

Naloxone Nasal Spray

In a landmark decision, the US FDA has approved the first over-the-counter (OTC) naloxone nasal spray to counter the rising opioid epidemic. This 4 mg nasal spray can be used by anyone to reverse the effects of an opioid overdose. According to the County of Los Angeles Public Health, the United States recorded 100,000 opioid overdose deaths in a one-year period for the first time in November 2021, largely fueled by fentanyl, a potent opioid that is over 50 times more potent than heroin.

OTC Narcan Will Improve Access and Availability

This approval is a major step in expanding access to naloxone and will allow people to easily obtain the medication, increase the number of locations where it's available, and help reduce opioid overdose deaths in the country. The FDA Commissioner, Robert M. Califf, MD, stated in a press release that "today's approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it's available and help reduce opioid overdose deaths throughout the country."

Cost and Availability of OTC Narcan

The price of the OTC Narcan nasal spray will be determined by Emergent BioSolutions, the drug manufacturer. The company stated that the product should be available in the US by late summer, but it has not yet disclosed the cost. Although naloxone is already available nationwide to people with a prescription, the federal government has made it legal for pharmacies and healthcare facilities to distribute naloxone to people without a prescription. But the availability and cost of naloxone to people without a prescription vary across states.

Expanding Access to Narcan Hinges on Affordability

The cost of OTC Narcan nasal spray will play a significant role in expanding access to the medication. While making naloxone available over-the-counter is a critical step in increasing access, affordability remains a major concern. José Martinez, a harm reduction associate at the National Harm Reduction Coalition, points out that access to naloxone can be free or low-cost through state-level standing orders, but some pharmacies have charged high amounts for the medication. He says that the cost of OTC Narcan nasal spray needs to be affordable to ensure access for everyone.

More Work Needed to Get Narcan into At-Risk Communities

Narcan nasal spray was introduced in 2016 to be used by non-healthcare professionals. However, only the 4 mg nasal spray has been approved for over-the-counter sale. As efforts continue to curb overdoses in the US, the focus needs to be on ensuring that overdose-arresting medications reach the communities most affected. The COVID-19 pandemic has added to the challenge of reaching these communities, and more work is needed to ensure that naloxone is readily available where it is most needed.

Conclusion

The approval of OTC Narcan nasal spray by the FDA is a significant step in expanding access to naloxone and reversing the effects of an opioid overdose. However, affordability remains a major concern, and efforts need to be made to ensure that the medication is accessible to everyone. In addition, more work is needed to ensure that naloxone reaches the communities most affected by the opioid epidemic.

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