FDA gives the ok for opioid overdose reversal drug to be sold over the counter

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

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

FDA Commissioner Dr Robert Califf said: ‘Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country.’

Narcan could become available at big box retailers, vending machines, supermarkets, and convenience stores as soon as this summer. 

A panel of outside experts voted unanimously last month to broaden access to the drug in the hope of avoiding another record-setting year for fatal drug overdoses. 

The above graph show the CDC estimates for the number of deaths triggered by drug overdoses per 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 must keep it behind the counter. And even without the necessity of a doctor’s order, many people feel reluctant to approach a pharmacist for the medication, wary of the stima attached to drug misuse. 

FDA leadership cannot guarantee that the medication will be free or even cheap. The cost of a single naloxone rescue kit ranges from approximately $22-$60 for intranasal kits. Price is determined by Narcan’s manufacturer, Emergent BioSolutions. 

Dr Califf said: ‘We encourage the manufacturer to make accessibility to the product 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 drug into the nose and spraying it.

The spray is impressively effective. A recent study by Brigham and Women’s hospital in Massachusetts found that over 93 percent of people given naloxone survived their overdose. 

When inhaled, the medicine is absorbed through mucous membranes in the nose, rapidly entering the bloodstream and traveling to the brain.

Once there, the medicine competes with opioids attaching themselves to receptors in the brain. It attaches to the brain’s receptors, replacing the opioid.

This blunts the effects of opiates on the brain, stopping an overdose from progressing.

It’s also easy enough for a layperson without medical training to use. 

Easy access to the nasal spray has never been more crucial. 

Within the mass of overdose deaths confirmed over the past couple of years, exacerbated by the pandemic, a vast majority were caused by the synthetic opiate fentanyl. 

Of the roughly 107,000 deaths confirmed in 2021, roughly 70 percent are attributed to fentanyl. 

The common drug adulterant is highly potent and fatal in large doses. The equivalent of five grains of salt worth of the synthetic opioid is enough to cause death.

The drug is 50 to 100 times stronger than morphine. It is cheap, relatively easy to smuggle into the US, and cost effective for dealers to mix it into their supplies, which saves them money and can extend or boost the high experienced by users. 

But many users do not even know they’re ingesting fentanyl when they buy their drugs. It’s now found in everything from cocaine to molly and street benzodiazepines like Xanax.