FDA Approves Narcan For Over-The-Counter Use

The Popular Overdose Reversal Drug Is Now Available Without A Prescription

The US Food and Drug Administration (FDA) on Wednesday approved the sale of the life-saving overdose reversal drug, Naloxone, also known as Narcan, without a prescription. The approval comes after months of hearings involving addiction experts and the Maryland-based company Emergent BioSolution, which is the largest manufacturer of the Opioid treatment nasal spray.

Addiction experts and advocates have long sought the approval of over-the-counter Narcan, claiming that it will improve access to a life-saving drug. However, the exact impact and scope of the approval will not be immediately clear.

What Is Narcan?

Narcan is an Opioid-agonist, meaning it binds to Opioid receptors in the brain, which can reverse and block the effects of Opioids like Heroin, Morphine, Oxycodone, and even Fentanyl. The approved version of Narcan is a four-milligram nasal spray that can be easily administered by someone with little to no medical training.

While Narcan is incredibly effective at reversing the effects of an Opioid overdose, it cannot combat the effects of other drugs, such as Xylazine which is currently plaguing many cities across the country.

Narcan can potentially reverse respiratory depression, restore breathing, and improves other symptoms of an Opioid overdose. It does not work nor is intended to work on reversing overdoses caused by other classes of drugs.

The move to make Narcan more widely available is seen as a strategic move by the FDA to help control the Opioid Epidemic. Currently, more than 100,000 Americans die every year from a drug overdose, of which nearly 75% involve the Synthetic Opioid Fentanyl. Along with the approval, Narcan has been distributed to police and first responders nationwide.

What Does The FDA Approval Mean?

The approval of over-the-counter Narcan is a long-awaited, welcome sign of progress by addiction experts and overdose prevention advocates across the country. With the FDA now ruling that Narcan can be bought without a prescription, Emergent BioSolution says it will become available on shelves by late summer. Other brands of Naloxone, including injectable solutions, will not be available yet, but they could be soon.

Before the ruling on Wednesday, Narcan was already available at retail pharmacies nationwide. Nearly every state had what is known as “standing orders,” meaning pharmacists could distribute the drug to whoever asked for it, regardless of prescription.

It’s important that if someone administers Narcan to an individual suspected of having an Opioid overdose, 911 is called, and emergency medical attention is still sought. Even after Narcan is administered, the effects don’t stick around for long, and the drug causing the overdose may still linger in the body.

While standing orders have been an important part of harm reduction efforts, addiction experts say that this requires people to be comfortable enough to approach a pharmacist and make a request, which implies that either they or someone they know is abusing drugs. Additionally, experts say people also reportedly worried about their health insurance providers finding out about them purchasing Narcan with their insurance card.

Making Narcan available over-the-counter, instead of requiring somebody to see a pharmacist, will help reduce the risk that stigma will prevent somebody from obtaining the drug in the first place.

What’s Next?

With Narcan being made available over the counter, the next major step to take is teaching people how to use it properly. In the hearings held last month in the lead-up to the FDA’s ruling, Emergent BioSolution was ordered to conduct a study examining whether untrained people could properly follow directions for using Narcan.

The study, which the FDA used to help guide their ruling, had numerous errors reported by people attempting to use the nasal spray device. The FDA suggested Emergent make several changes to how the directions will be displayed on the packaging and said the device could be safely used “without the supervision” of a health care worker.

Still, more public education is needed to teach others how to properly administer Narcan. Narcan is not a medication needed only for those who use Opioids. Knowing how to properly administer Narcan is a skill that everyone should know, similar to CPR or the Heimlich maneuver.

Find Help Today

While Narcan and other harm reduction methods are an essential part of combatting the Opioid Epidemic, the end goal of any recovery plan should be sobriety. The safest way to stop Opioid abuse is to seek help at an inpatient treatment center. Here, you can safely detox under constant medical supervision, which has been shown to greatly improve treatment success.

To find help for yourself or a loved one today, or to learn more about Opioid addiction treatment, contact a treatment provider for free today.