FDA approves over-the-counter sale of Narcan

Narcan, a drug that reverses opioid overdoses, will be available in pharmacies and other establishments without a prescription, the Food and Drug Administration (FDA) announced Wednesday.

The decision responds to the alarming rate of deaths from opioid overdose that prevails in the country and, it is expected, will decrease now that access to it is facilitated.

More than 564,000 people have died from an opioid overdose between 1999 and 2020, according to the Centers for Disease Control and Prevention. In particular, overdoses from synthetic opioids such as fentanyl have skyrocketed in recent years, reaching 71,000 people in 2021, 18% more than in the previous year.

A large part of these deaths could be prevented with timely access to Narcan, which will soon be available not only in pharmacies, but also in gas stations, markets and even vending machines.

“Today’s approval of the over-the-counter nasal spray will help improve access to naloxone, increase the number of places where it is available, and help reduce opioid overdose deaths across the country. We encourage the manufacturer to make product accessibility a priority by making it available as soon as possible and at an affordable price,” said FDA Commissioner Robert Califf.

What is Narcan that reverses opioid overdose and how is it used?

Narcan is a nasal spray of the drug naloxone that blocks the effect of opioids on the brain. Until now, some states allowed pharmacists to dispense it to anyone who requested it, but most pharmacies chose not to.

Each package contains two nasal sprays and is currently covered by insurance policies, with no or very low copayments of no more than $10. But most insurers don’t cover over-the-counter drugs, so cost could be a factor that continues to limit access.

The manufacturer, Emergent BioSolutions, has not yet indicated an over-the-counter price for Narcan.

The spray is easy to use. The first dose is administered into the nostril of the overdosing person and then 911 should be called immediately. If the individual is still unconscious after 2-3 minutes, the instructions say to repeat the procedure a second time.

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