FDA Panel Recommends OTC Status for Narcan


Narcan Nasal Spray | Image by Hanson L/Shutterstock

The U.S. Food and Drug Administration (FDA) may soon reclassify a prescription opioid countermeasure as an over-the-counter (OTC) medication.

A panel of medical experts on the FDA’s Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) convened recently to discuss whether to allow Narcan, a nasal spray version of the drug naloxone, to be sold without a prescription. The drug, made by Emergent BioSolutions, is used to restore breathing during opioid overdoses.

The February 15 discussion focused primarily on whether untrained users would be able to administer the drug in an emergency situation.

During the meeting, Emergent BioSolutions presented a study that indicated people of different ages and backgrounds could reliably understand and administer the medication, though some participants had difficulty locating the instructions on the packaging. Emergent said it would rectify this issue by adding visuals and placing the instructions on a single panel.

The panel ultimately decided to recommend the change to non-prescription status. However, the panel’s endorsement is nonbinding, and the FDA is expected to make a final decision regarding the medicine’s status by the end of March.

If approved, Narcan would become the first opioid overdose treatment drug available over the counter.

In December, a similar naloxone nasal spray product sold under the name Rivive and manufactured by Harm Reduction Therapeutics Inc. was granted a priority review by the FDA for consideration for OTC status, as The Dallas Express previously reported. The company said the FDA gave it a target approval date of April 28, The Wall Street Journal reported.

However, despite naloxone’s current status as a prescription medication, many states already have access laws that allow individuals to get the drug without needing a personalized prescription.

In Texas, naloxone is currently available as a behind-the-counter (BTC) medication, which means that if the pharmacy has a standing order from a physician or public health official, it can dispense the medication to anyone who asks for it. In addition, the drug is available for free through some non-profit community outreach programs.

One such organization in North Texas, Drews’s 27 Chains, provides education and awareness for this type of medication, as previously reported by The Dallas Express. The organization distributes Narcan to first responder departments.

Naloxone is merely a first-step emergency treatment for someone who has overdosed on opioids, and caregivers are urged to call 9-1-1 immediately after administering the drug. The medication may trigger severe opioid withdrawal symptoms, such as increased heart rate and blood pressure, shivering, nausea, diarrhea, and vomiting.

The need for naloxone is growing amid increasing numbers of overdoses, especially from opioids, and subsequent deaths across the nation.

Prescription opioid overdoses, despite briefly dropping in 2018 and 2019, have been on the rise again since 2020, per the National Center for Health Statistics (NCHS).

This could have to do in part with the pandemic shutdowns in 2020, during which overdoses rose across the board.

Further, research reported in 2019 in The Journal of the International Association for the Study of Pain noted that the increasing prevalence of obesity “has been accompanied by an increase in prescription opioid use. Obesity, through its association with pain, may represent an important contributor to opioid use.”

“Although interpretation is limited by the cross-sectional nature of the associations, our findings suggest that the obesity epidemic may be partially responsible for the high prevalence of prescription opioid use in the United States,” said researchers.

Obesity rates have also increased steadily in recent years, according to the NCHS.

Further contributing to the rise in overdoses and the subsequent necessity of naloxone is the ongoing fentanyl crisis. Fentanyl is a type of opioid.

Some panel members at the February 15 meeting advocated for urgency in approving OTC status for Narcan amid the growth in overdoses.

“There’s perhaps a far greater risk of delaying the availability of the product given the climate of this crisis and its devastating consequences,” said Maria Coyle, chair of the panel, according to WFAA.

“Perfect should not be the enemy of the good and the evidence we saw today provides clear indication that the drug can be used without the direction of a health care provider,” Dr. Brian Bateman of Stanford University said in the meeting, per WFAA.

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