FDA clears opioid overdose reversal drug to be sold without a prescription

Narcan, the nasal spray that quickly reverses opioid overdoses, can now be sold without a prescription, the Food and Drug Administration said.

The approval announced Wednesday caps a long-running battle by public health officials and addiction medicine experts to make the antidote more readily available, a move they say would save hundreds of thousands of lives. .

FDA Commissioner Dr. Robert Califf said: “Today’s approval of over-the-counter naloxone nasal spray will help improve access to naloxone, increase the number of places where it is available and reduce opioid overdose deaths nationwide.”

Narcan could be available at big-box retailers, vending machines, supermarkets and convenience stores as early as this summer.

A group of outside experts voted unanimously last month to expand access to the drug in hopes of averting another record year for fatal overdoses.

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 requests 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 hesitant to go to a pharmacist for the drug, wary of the stimulation associated with drug abuse.

FDA management cannot guarantee that the drug will be free or even inexpensive. The cost of a single naloxone rescue kit ranges from about $22 to $60 for intranasal kits. Pricing is determined by Narcan’s manufacturer, Emergent BioSolutions.

Dr Califf said: “We encourage the manufacturer to make product accessibility a priority by making it available as soon 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 medicine 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% of people who received naloxone survived their overdose.

When inhaled, the drug is absorbed through the mucous membranes of the nose, quickly enters the bloodstream and travels to the brain.

Once there, the drug competes with opioids that bind to receptors in the brain. It attaches to receptors in the brain, replacing the opioid.

This lessens the effects of opiates on the brain, preventing an overdose from progressing.