The FDA approves a nasal spray that treats fentanyl AND opioid overdoses as they occur for over-the-counter use — meaning it can be sold in vending machines and major department stores
Narcan, the nasal spray that quickly reverses opioid overdoses, can now be sold over-the-counter without a prescription, the Food and Drug Administration said.
The approval, announced Wednesday, caps a long-fought battle by public health officials and addiction medicine experts to make the antidote more readily available, a move they argued would save hundreds of thousands of lives.
FDA Commissioner Dr. Robert Califf said: “Today’s approval of the over-the-counter naloxone nasal spray will help increase access to naloxone, increase the number of places it is available and help reduce opioid overdose deaths across the country to reduce.”
Narcan could be available at major retailers, vending machines, supermarkets, and convenience stores as early as this summer.
A panel of outside experts voted unanimously last month to expand access to the drug in hopes of avoiding another record year for fatal overdoses.
The chart above shows CDC estimates for the number of drug overdose deaths each year
Fentanyl-related deaths in the US continue to spiral out of control
Narcan is already available without a prescription in all 50 states, where state leaders have issued standing orders for pharmacists to sell the drug to anyone who asks for it.
But not all pharmacies carry it and those that do have to keep it behind the counter. And even without the need for a doctor’s prescription, many people are reluctant to approach a pharmacist about the drug because they are wary of the stima associated with drug abuse.
FDA leadership cannot guarantee that the drug will be free or even cheap. The cost of a single naloxone rescue kit ranges from about $22 to $60 for intranasal kits. The price is set by Narcan’s manufacturer, Emergent BioSolutions.
dr Califf said, “We encourage the manufacturer to make product accessibility a priority by making it available as quickly as possible and at an affordable price.”
Narcan, also known as naloxone, is an opioid antagonist. It is used by inserting the nozzle of the drug into the nose and spraying it.
The spray is impressively effective. A recent study from Brigham and Women’s Hospital in Massachusetts found that over 93 percent of people given naloxone survived their overdose.
When inhaled, the drug is absorbed through the mucous membranes in the nose, quickly enters the bloodstream and travels to the brain.
There, the drug competes with opioids, which bind to receptors in the brain. It binds to the brain’s receptors and replaces the opioid.
This weakens the effects of opiates on the brain and prevents an overdose from progressing.
It is easy to use, even for a layperson with no medical training.
Easy access to nasal spray has never been more important.
Of the mass of overdose deaths confirmed in recent years and exacerbated by the pandemic, a large majority were caused by the synthetic opiate fentanyl.
Of the approximately 107,000 confirmed deaths in 2021, around 70 percent are attributed to fentanyl.
The common drug adulterator is highly potent and deadly in large doses. The equivalent of five grains of salt of the synthetic opioid is enough to cause death.
The drug is 50 to 100 times stronger than morphine. It’s cheap, relatively easy to smuggle into the US, and inexpensive for traders to mix into their stashes, which saves them money and can prolong or amplify the high experienced by users.
But many users don’t even know they’re taking fentanyl when they buy their medication. It’s now found in everything from cocaine to molly and street benzodiazepines like Xanax.