FDA Approves Over-The-Counter Version of Life-Saving Opioid Overdose Drug

The Food and Drug Administration (FDA) recently approved an over-the-counter version of naloxone, an opioid overdose reversal drug, NBCNews reports.

This drug was previously accessible only with a prescription and was sold under the brand name Narcan by drugmaker Emergent BioSolutions.

Many states, however, had devised workarounds that allowed people to obtain it directly from pharmacists, and it was also available at convenience stores, grocery stores, gas stations, and online, but the manufacturer will determine the availability and price.

Life-saving Overdose Medication

This new FDA decision is anticipated to increase access to this life-saving medication, potentially saving more lives. Dr. Scott Hadland, a pediatrician and addiction specialist at MassGeneral Hospital for Children in Boston, tells NBCNews that Narcan can save a life in minutes, which is indispensable.

According to the company, the over-the-counter Narcan will be sold as a single dose as a nasal spray and will be available in late summer.

Officials from the FDA indicated in an announcement that once approved, it could be sold in convenience stores, supermarkets, and even vending machines.

The New York Times reported that two federal panels of addiction experts unanimously recommended in February that the overdose-reversing nasal spray be made widely accessible without a prescription, a significant step in the effort to reduce rapidly rising drug fatalities.

The Problem with Rising Cases of Drug Overdose

According to the Centers for Disease Control and Prevention (CDC), drug overdoses were the major cause of accidental deaths in the United States in 2021, killing more than 107,000 people, with opioids accounting for more than 80,000 deaths. The FDA highlights that some of the most recent cases were primarily driven by synthetic opioids like illicit fentanyl.

Dr. Hadland also has noticed an increase in teenagers and young adults overdosing. Hadland notes that most overdose deaths among young people occur at home, usually when someone nearby can respond. However, the majority of young people who overdose do not receive Narcan and are dead by the time EMS arrives.

Making it available over the counter will open up a new avenue of access, particularly for young people and families who have previously been overlooked in nationwide efforts to distribute Narcan.

How much will the drug cost?

The company claims that the over-the-counter version of naloxone will come in a larger box with images and more detailed instructions to assist people in more easily administering the drug.

But how much will the medication cost? According to GoodRx, which tracks drug prices, a two-dose box of prescription-only Narcan costs around $130.

This new development is expected to increase naloxone access, reducing opioid overdose deaths nationwide. The FDA is confident that naloxone nasal spray will help improve access to naloxone, increase the number of locations where it is available, and reduce opioid overdose deaths across the country.

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